[Summary text]
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Appetitforstyrrelser
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt, CI
ADHD kernesymptomer, forældrebedømt, CI
Frafald pga bivirkninger, n
Appetitforstyrrelser, n
Søvnforstyrrelser, n
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Control
Included criteria: Age 6-12 years old. Symptom severity of 1.5 above age and gender norms in ADHD-RS rating
Excluded criteria: Serious medicall illness, history of phycosis or bipolar disorder, weight 20kg or >65kg, uncontrolled hypertension, previous nonresponse to atomoxetine, alcohol or drug abuse
Pretreatment: Baseline characteristics were similar
Intervention Characteristics
Intervention 1
Intervention 2
Control
Frafald pga bivirkninger
Vægttab
Appetitforstyrrelser
Sponsorship source: Funded by Lilly
Country: USA
Setting: 14 outpatient sites
Authors name: Stan L Block
Institution: Kentucky Pediatric Research
Email: slblock@pol.net
Address: Kentucky Pediatric Research 201 S. 5th street Bardstown, KY 40004
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, lærerbedømt
ADHD kernesymptomer, forældrebedømt
Livskvalitet
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, lærerbedømt
ADHD kernesymptomer, forældrebedømt
Adfærdsforstyrrelser, lærerbedømt
Adfærdsforstyrrelser, forældrebedømt
Vægttab
Appetitforstyrrelser
Søvnforstyrrelser
Livskvalitet
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Appetitforstyrrelser
Alvorlige bivirkninger total
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Patients with the age og 6-15 years, met the DSM-IV-TR criteria of ADHD and had a ADHDRS-IV-parent:Inv total score > =1.5 SD above the age norm
Excluded criteria: History of bipolar disorder, psychosis or pervasive developmental disoorder, any other relevant nonpsychiatric condition, general impairments of intelligence, alcohol or drug abuse, were involved in psychotherapy, were taking any medication with sympthomimetic activity or deemed to have difficulties to follow study procedures or to communicate with site personnel.
Pretreatment: Baseline characteristics were similar in teh atomoxetine and placebo group
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Appetitforstyrrelser
Livskvalitet
Sponsorship source: Lilly research
Country: Spain
Comments: Protocol: NCT00191945
Authors name: Escobar
Institution: Lilly research laboratory
Email: escobar_rodrigo@lilly.com
Address: Lilly research laboratory, Evenida Industria 30
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: A total score on the ADHD-RS-IV of at least 25 for boys and 22 for girls. Normal intellegence, no ADHD medication
Excluded criteria: Weight 20kg or >60kg. Serious medical illness, history og bipolar I or II disorder, pervasive developmental disorder, anxiety dosorder, history of seizure, or EEG abnormalities, alcohol or drug abuse or other psychoactive medication other then the study drug during the study
Pretreatment: No apparent differences at baseline
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer
ADHD kernesymptomer
ADHD kernesymptomer
Adfærdsforstyrrelser
Adfærdsforstyrrelser
Vægttab
Apetitforstyrrelser
Søvnforstyrrelser
Sponsorship source: Eli Lilly Co
Country: Taiwan
Setting: 3 outpatient sites
Authors name: Susan Gau
Institution: Dep. of psychiatry
Email: lee_pjil@lilly.com
Address: 11F, 365, Fu Hsin N. Road
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt
Vægttab, mean change
Appetitforstyrrelser
Søvnforstyrrelser
Livskvalitet
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Placebo
Included criteria: Male and female children/adolescents (6–17 years old) with adiagnosis of ADHD of at least moderate severity, as defined by abaseline ADHD-RS-IV with a total score of 32 or higher and aminimum Clinical Global Impression-Severity (CGI-S) score of 4,were enrolled in the study. Those with age-appropriate intellectualfunctioning; blood pressure measurements within the 95th percen-tile for age, sex and height; and the ability to swallow tablets orcapsules were included. Girls of childbearing potential had to havea negative urine pregnancy test at screening and baseline and tocomply with any protocol contraceptive requirements. In addition,participants and their parent/legal guardian had to be willing, able and likely to fully comply with the study procedures and restrictionsdefined in the protocol. Subjects who took between 80% and 120%of their total medication were considered to be compliant with thestudy protocol.
Excluded criteria: Exclusion criteria included: clinically significantillness, including a clinically significant abnormal screening visit;current, comorbid psychiatric diagnosis (except oppositional defiantdisorder [ODD]); history/presence of cardiac abnormalities, cardi-ovascular or cerebrovascular disease, serious heart rhythm abnorm-alities, syncope, tachycardia, cardiac conduction problems,exercise-related cardiac events or clinically significant bradycardia;orthostatic hypotension and/or a known history of hypertension;seizures; and glaucoma. In addition, those with a family history ofsudden cardiac death, ventricular arrhythmia or QT prolongation, apatient history of alcohol or substance abuse and those patientswith serious tic disorder, including Tourette's syndrome, wereexcluded. In addition, enrollment was managed to ensure thatapproximately 25% of those enrolled were adolescents and at least25% were female. Furthermore, at least 70% of those enrolled wereto come from European centers and the remaining 30% from USA/Canada
Pretreatment: Baseline characteristics were similar across treatmentgroups
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, observatør/kliniker bedømt
ADHD kernesymptomer, forældre
Frafald pga. bivirkninger
Alvorlige bivirkninger-totalt
ADHD kernesymptomer, observatør/kliniker bedømt
Appetitforstyrrelser
Søvnforstyrrelser
Angst/nervousness
Total severe adverse event
Sponsorship source: Funding for this study was provided by Shire Development, LLC.Shire Development, LLC was involved in the study design, collec-tion, analyses and interpretation of the data, and checking theinformation for scientific accuracy
Country: Spain
Setting: Multicenter
Comments: ClinicalTrials.gov identifier: NCT01244490 and EudraCT: 2010-018579
Authors name: Amaia Hervas
Institution: Child and Adolescent Mental Health Unit, University Hospital Mútua de Terrassa, UETD, Hospital SantJoan de Deu, Barcelona, Spain
Email: 32989ahz@comb.cat
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt, CI
Adfærdsforstyrrelser, forældrebedømt, SD
Frafald pga bivirkninger, n
Appetitforstyrrelser, n
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Children 6 to 12 years of age who metDiagnostic and StatisticalManual of Mental Disorders(4th ed.) criteria for ADHD, as assessedin clinical interviews and confirmed in parent interviews using theKiddie Schedule for Affective Disorders and Schizophrenia forSchool-Aged Children–Present and Lifetime Version,19were eli-gible to participate. All patients were required to meet a symptomseverity threshold, with a symptom severity score at least 1.5 SDsabove age and gender normative values, as assessed with theAttention-Deficit/Hyperactivity Disorder Rating Scale-IV-ParentVersion: Investigator-Administered and Scored (ADHD RS),20,21for the total score or either of the inattentive or hyperactive/impulsive subscales. Important exclusion criteria included seriousmedical illness, a history of psychosis or bipolar disorder, alcoholor drug abuse within the past 3 months, and ongoing use ofpsychoactive medications other than the study drug. Patients wererecruited by referral and by advertisement
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Appetitforstyrrelser
Sponsorship source: Lilly technology
Country: USA
Setting: 12 outpatient sites
Authors name: Douglas Kelsey
Institution: Lilly research laboratory
Email: Kelsey_douglas_K@lilly.com
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Patients were eligible to participate if they met the following criteria: at both visits, 1 and 2(screening and randomization), had a minimum score of 25for boys and 22 for girls, or[12 for their diagnostic sub-type on the Attention-Deficit/Hyperactivity Disorder Rat-ing Scale-IV-Parent Version: Investigator-Administeredand Scored [7], as well as a score ofC4 on the ClinicalGlobal Impressions-ADHD-Severity (CGI-ADHD-S [10])scale; had not taken any medication for the treatment ofADHD or completed washout procedures; had no signifi-cant abnormalities in laboratory results and baseline ECG;and were able to communicate suitably with the investi-gator and study coordinator.
Excluded criteria: Patients were excluded if they weighed\20 kg or[60 kg at study entry; experienced no clinical benefitafter an adequate trial with methylphenidate or amphet-amine (all patients were psychostimulant naıve, but it wasnot required by the protocol); had been treated, within the previous 30 days, with a drug (not including study drug)that had not received a regulatory approval for any indication at the time of study entry; had a history of bipolar Ior II disorder, psychosis, or pervasive developmentaldisorder; met DSM-IV criteria for an anxiety disorder (asassessed by the investigator and confirmed by theK-SADS-PL); had a history of any seizure disorder (otherthan febrile seizures) or prior electroencephalogram abnormalities related to epilepsy; had taken (or were taking) anticonvulsants for seizure control; were at serious suicidal risk or had a serious medical illness; or were pregnant or breast-feeding.
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Adfærdsforstyrrelser, forældrebedømt
Frafald pga bivirkninger
Vægttab
Appetitforstyrrelser
Sponsorship source: Financial disclosureDrs. Martenyi and Jarkova are employees andstockholders of Eli Lilly and Company. Dr. Zavadenko is a memberof the Lilly ADHD advisory board. The rest of the authors do not haveany financial disclosures to report. This study was funded by Eli Lillyand Company.
Country: USA
Comments: Clinical Trials Registry: NCT00386581,http://www.clinicaltrials.gov/.
Authors name: Ferenc Martenyi
Institution: Lilly Corporate Center, Lilly Research Laboratories
Email: martenyi_ferenc@lilly.com
Address: Lilly Corporate Center, Lilly Research Laboratories, Indianapolis, IN 46285, USA
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt
ADHD kernesymptomer, forældrebedømt
Adfærdsforstyrrelser, forældrebedømt
Frafald pga bivirkninger
Vægttab, mean change
Appetitforstyrrelser
Søvnforstyrrelser
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Children and adolescents, 6–16 years of age, who met DSM-IVcriteria for ADHD, as assessed by clinical interview and confirmedby the Schedule for Affective Disorders and Schizophrenia forSchool-Age Children—Present and Lifetime Version (K-SADS-PL)(7), were eligible to participate. All patients were required to meeta symptom severity threshold: a score at least 1.5 standard devia-tions above age and gender norms as assessed by the investigator-administered and -scored parent version of the ADHD Rating Am J Psychiatry 159:11, November 20021897MICHELSON, ALLEN, BUSNER, ET AL.Scale–IV (8). Comorbid psychiatric conditions were assessed clin-ically and with the K-SADS-PL
Excluded criteria: Important exclusion criteria in-cluded serious medical illness, a history of psychosis or bipolardisorder, alcohol or drug abuse within the past 3 months, and on-going use of psychoactive medications other than the study drug.Patients were recruited by referral and by advertisement
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, lærerbedømt
ADHD kernesymptomer, obsevatørbedømt
ADHD kernesymptomer, forældrebedømt
Appetitforstyrrelser
Sponsorship source: Lilly Corporate Center
Country: USA
Authors name: David Michelson
Institution: Lilly Corporate Center
Email: dmichelson@lilly.com
Address: Lilly Corporate Center, Indianapolis, IN46285
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: The study focused on newly diagnosed (time since diag-nosis3 months), treatment-naı ̈ve cases of ADHDdefined according to the criteria of the revised fourth edi-tion of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)2. The Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL) 20 was used at screening stage to confirm the diagnosis. Other inclusion criteria were: age between 6 and 15 years, and an ADHDRS-IV-Parent:Inv total score1.5 standard deviations above the age norm21for their diagnostic subtype
Excluded criteria: Exclusion criteria were patients with history of bipolar disorder, psychosis,pervasive developmental disorder or seizure disorder, glau-coma or hypertension, intelligence quotient (IQ) below 70at investigator’s judgment, any pervasive developmental disorder, alcohol or drug abuse within the past 3 months,planned start of structured psychotherapy at any time during the study, and taking any regular psychoactive or sympathomimetic medication.
Pretreatment: Baseline characteristics were similar in both groups
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt, CI
Adfærdsforstyrrelser, forældrebedømt SE
Appetitforstyrrelser, n
Sponsorship source: This clinical trial has been funded by Lilly Research Laboratories,Alcobendas, Spain
Country: Spain
Setting: 12 specialized outpatient settings
Comments: study internal code: B4Z-XM-LYDM, identifier: NCT00191945
Authors name: Alonso Montoya
Institution: Lilly Research Laboratories
Email: escobar_rodrigo@lilly.com
Address: Rodrigo Escobar. EU Medical Lilly ResearchLaboratories. Avenida Industria, 30. 28108 Alcobendas, Spain
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt, CI
ADHD kernesymptomer, forældrebedømt, CI
Frafald pga bivirkninger, n
Appetitforstyrrelser, n
Søvnforstyrrelser, n
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Should meet the DSM-IV criteria for ADHD. Have a ADHD-RS:IV of at least 1.5 standard deviation above the gender and age norm
Excluded criteria: Poor metabolizers of CYP2D6. Weight 25kg at study entry. Documented history of bipolar I or II disorder or any history of seizure, organic brain disease, alcohol and drug abuse, prior medical condition or taking any osychotropic medication.
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Vægttab
Appetitforstyrrelser
Appetitforstyrrelser
Søvnforstyrrelser
Sponsorship source: Eli Lilly Company
Country: USA
Authors name: Thomas Spencer
Institution: Eli Lilly Company
Email: heilig@lilly.com
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Appetitforstyrrelser
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
ADHD kernesymptomer, obsevatørbedømt
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Intervention 2
Intervention 3
Control
Included criteria: This multicenter study was conducted in 245 Japanese pe-diatric patients with ADHD at 41 study centers in Japan.Japanese children and adolescents who were at least 6 yearsold but younger than 18 years of age were eligible to partici-pate if: (1) they met the DSM-IV criteria for ADHD by clinicalassessment (American Psychiatric Association 1994) and (2)their diagnosis was confirmed in structured interviews withinvestigators using the behavior module for ADHD of theKiddie Schedule for Affective Disorders and Schizophreniafor School- Aged Children–Present and Lifetime Versions (K-SADS-PL) (Kaufman et al. 1997). Also, patients had to have aClinical Global Impressions–ADHD-Severity (CGI-ADHD-S)assessment score3 (Guy 1976; National Institute of MentalHealth 1985) and a symptom severity score at least 1.5 stan-dard deviations (SD) above Japanese pediatric age and gendernorms on the Attention-Deficit=Hyperactivity Disorder Rat-ing Scale-IV–Parent Version:Investigator Administered andScored=Translated and Validated in Japanese (ADHD RS-IV-J:I) (DuPaul et al. 1998; Yamazaki et al. 2001).Patients were also required to be of normal intelligence (IQ80). For patients younger than 17 years of age, this wasassessed by the Wechsler Intelligence Scale for Children–Third Edition (WISC-III). Individual investigators determinednormal intelligence in patients 17 years and older.
Excluded criteria: Important exclusion criteria included patients who tookany antipsychotic medication within 26 weeks of study visit 1,had a history of bipolar disorder or psychosis, or were de-termined by the investigator to be at suicidal risk
Intervention Characteristics
Intervention 1
Intervention 2
Intervention 3
Control
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Appetitforstyrrelser
Sponsorship source: This research was funded by Eli Lilly Japan K.K
Country: Japan
Authors name: Michihiro Takahashi,
Institution: Lilly Research Laboratories Japan, Kobe, Japan.
Email: Takahashi_michihiro@lilly.com
Address: Dr. Michiro TakahashiLilly Research Laboratories JapanEli Lilly Japan K.K.Sannomiya Plaza Bldg.7-1-5, Isogamidori, Chuo-kuKobe, 651-0086 Japa
See NICE guideline "Attention deficit hyperactivity disorder: diagnosis and management" 2018
Frafald pga bivirkninger
Alvorlige bivirkninger total
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: 6-12 years of age. ADHD diagnosis according to diagnostic and statistical manual of mental disorder
Excluded criteria: Previous treatment with atomoxetine, clinical over- or underweight, history of bipolar disorder, psychosis, pervasive developmental disorder, seizure disorder, serious suicidal risk and other acute/unstable medical condition
Pretreatment: Treatment groups were comparable at baseline
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Vægttab
Appetitforstyrrelser
Alvorlige bivirkninger - total
Sponsorship source: Lilly Deutschland
Country: Germany
Comments: NCT00546910
Authors name: Peter M. Wehmeier
Institution: Dep. of child and adolescent Psychiatry
Email: Peter.Wehmeier@vitos-weilmuenster.de
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Placebo
Included criteria: Girls and boys aged 6 to 12 years with a diagnosis ofADHD according to Diagnostic and Statistical Manual ofMental Disorders (4th ed., text rev.; DSM-IV-TR; APA,2000) criteria (APA, 2000) were eligible. The diagnosiswas confirmed using the “Diagnose-ChecklisteHyperkinetische Störungen” (Diagnostic Checklist forHyperkinetic Disorders [DCL-HKS]), a structured instrumentthat is routinely used for the diagnostic assessment ofADHD in Germany (Döpfner Lehmkuhl, 2000). Theitems of this instrument correspond to those of theADHD-RS (DuPaul et al., 1998; Faries et al., 2001). Thepresence of comorbid disorders frequently associated withADHD was not exclusionary.
Excluded criteria: The exclusion criteria comprisedprevious treatment with ATX, treatment with psychotropicmedication other than the study drug, clinicallyrelevant over- and underweight, a history of bipolar disorder,psychosis, pervasive developmental disorder, seizuredisorder (other than febrile seizures), serious suicidal risk,and other relevant acute or unstable medical conditions.Psychotherapy initiated prior to the study was acceptable.
Pretreatment: The two treatment groups were comparable in terms of baseline characteristicsand baseline ADHD severity as measured by theADHD-RS
Intervention Characteristics
Intervention
Placebo
ADHD kernesymptomer, observatør/kliniker bedømt
ADHD kernesymptomer, forældre
Frafald pga. bivirkninger
Alvorlige bivirkninger-totalt
Sponsorship source: The author(s) disclosed receipt of the following financial supportfor the research and/or authorship of this article: The study wasfunded by Lilly Deutschland, the German affiliate of Eli Lilly andCompany
Country: Germany
Setting: Multicenter study
Comments: Clinical trial: NCT00546910
Authors name: Peter M. Wehmeier
Institution: Department of Child and Adolescent Psychiatry, Central Institute of Mental Health
Email: peter.wehmeier@vitos-weilmuenster.de
Address: Peter M. Wehmeier, Department of Child and Adolescent Psychiatry,Central Institute of Mental Health, Post Box 12 21 20, 68072 Mannheim,Germany.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Age 8-12 years old. ADHD diagnosis, symptom severity least 1.0 SD above gender and age norm. Mean Conners Parent rating scale index score at least 1.5 SD above sex and age norm
Excluded criteria: Unavailability of a primary treacher willing to keep telefone appointments and to provide ratings. Evidence of significant intelectual deficits, serious medical illness or use of psychotropic medication.
Pretreatment: Baseline characteristics across groups were similar
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Adfærdsforstyrrelser, forældrebedømt
Frafald pga bivirkninger
Vægttab
Appetitforstyrrelser
Sponsorship source: Eli Lilly and company
Country: USA
Authors name: Margaret Weiss
Institution: Lilly research laboratory
Email: allenaj@lilly.com
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Males and females, aged 6–12 years (inclusive), with a DSM-IV diagnosis of any ADHDsubtype, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia forSchool-Age Children-Present and Lifetime Version (K-SADS-PL),15 and a rating of 4 orhigher on the Clinical Global Impression-ADHD-Severity Scale (CGI-ADHD-S) wereenrolled at 23 sites (Study 1: 10; Study 2: 3; Studies 1 and 2: 10) in the United States(September 2007 - July 2008). For all sites, an institutional review board approved the studyprotocol. A parent/caregiver of each youth provided informed consent, and subjects ages 7–12 provided written assent
Excluded criteria: aged 6 to 12 years, treated with ABT-089. We hypothesized that ABT-089 would besuperior to placebo in the treatment of ADHD symptomatology. Secondarily, wehypothesized improvement in functional outcomes and examined the tolerability and safetyof ABT-089 in this pediatric population.METHODStudy PatientsMales and females, aged 6–12 years (inclusive), with a DSM-IV diagnosis of any ADHDsubtype, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia forSchool-Age Children-Present and Lifetime Version (K-SADS-PL),15 and a rating of 4 orhigher on the Clinical Global Impression-ADHD-Severity Scale (CGI-ADHD-S) wereenrolled at 23 sites (Study 1: 10; Study 2: 3; Studies 1 and 2: 10) in the United States(September 2007 - July 2008). For all sites, an institutional review board approved the studyprotocol. A parent/caregiver of each youth provided informed consent, and subjects ages 7–12 provided written assent.
Pretreatment: Baseline characteristics did not differ between treatment groups within or between studies
Intervention Characteristics
Intervention 1
Control
ADHD kernesymptomer, obsevatørbedømt
Frafald pga bivirkninger
Søvnforstyrrelser
Sponsorship source: Abbott
Country: USA
Comments: M06-888 (Study 1): A Safety and Efficacy Study of ABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD), Clinicaltrials.gov, NCT00528697; M10-345 (Study 2): Safety and Tolerability Study ofABT-089 in Children With Attention-Deficit/Hyperactivity Disorder (ADHD), Clinicaltrials.gov, NCT00640419
Authors name: Timothy E. Wilens,
Institution: Massachusetts General Hospital, Pediatric Psychopharmacology Unit
Email: twilens@partners.org
Address: Massachusetts General Hospital, Pediatric Psychopharmacology Unit, 55 Fruit Street,YAW 6A, Boston, MA 02114,
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comment: Randomization done by computerized Interactive voice response system
Quote: "The randomization schedules were generated by validated software and implemented in a blinded manner by using an interactive voice-response tele- phone system to dispense study medication."
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Not fully described:The study was a randomized,double-blind, placebo-controlled,parallel design multisite trial thatwas conducted at 10 investigationalsites in the United States
Quote: "At the beginning of this period, patients who did not respond to the 6-week period of parent support were randomly assigned to treatment with atomoxetine or placebo in a ratio of 3:1 (i.e. with approximately 75% of patients receiving atomoxetine and 25% of patients receiving placebo). Patients"
Judgement Comment: Not fully described how the randomization eas performed
Judgement Comment: Randomization was based on a computer-generated random sequence using interactive voice response system, stratified by patients age
Judgement Comment: Randomization was done via a centralized computer-generated random sequence
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Mentioned as randomized. Unclear how it was done.
Quote: "Randomization occurred at baseline (day 0) and eligible participants were rando- mized, using a 1:1:1 ratio, to GXR, ATX or placebo (automatically, randomly assigned by the interactive voice response system). Alloca- tion to treatment was stratified within age group (6–12 or 13–17 years) and country."
Judgement Comment: Randomization was generated by validated software and implemented using a voice-response phone system to dispense study medication.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Quote: "Patients were randomized using computer-generated codes via an interactive voice response system. The"
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Quote: "After two pretreatment assess- ment visits, patients were randomly assigned to receive one of three treatments: atomoxetine (0.8–1.8 mg/kg per day, adminis- tered as a divided twice-daily dose), osmotically released meth- ylphenidate (18–54 mg/day, administered as a single morning dose), or placebo. The randomization ratio was 3:3:1 for atomox- etine, osmotically released methylphenidate, and placebo, re- spectively."
Judgement Comment: Mentioned as randomized. Unclear how it was done.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
Judgement Comment: See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Quote: "Randomization using an interactive voice system, stratified by site, was performed at visit 2 (week 0)."
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Computer-randomization
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No information on sequence generation has been provided
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: All clinical material was blinded All clinical material was blinded
Quote: "Study drug materials for all treatment groups were identical in appearance."
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: placebo medication was identical to intervention in appearance placebo medication was identical to intervention in appearance
Judgement Comment: Nothing mentioned
Judgement Comment: not described
Judgement Comment: Study medication was packed in such a way that dose adjustment did not compromise the double-blind design
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Nothing mentioned.
Judgement Comment: Nothing mentioned
Judgement Comment: Drug materials for all treatment groups in the study were identical in apperance.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Quote: "Each patient’s genotype was reported to the investigative sites in a sealed envelope for blinding purposes, not to be opened except in the case of emergency."
Quote: "The study drug for all treatment groups was identical in appearance."
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Quote: "The study drugs were administered by using a double-dummy design. Patients in each treatment arm took three identically ap- pearing capsules consisting of atomoxetine, osmotically released methylphenidate, or placebo"
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
Judgement Comment: See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Quote: "identical placebo capsules were available"
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Insufficient information on sequence generation, but capsules identical in appearance
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No information on allocation concealment has been provided
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: The drug labeling system was available for the investigator Quote: " Patients were assigned in a1:1 ratio to double-blind treatment consisting of either placebo oratomoxetine (0.5 to 1.5 mg/kg/day""All clinical trial materials were blinded when provided tothe investigative site, and emergency codes, generated by a computerizeddrug-labeling system, were available to the investigator"
Judgement Comment: Mentioned as blinded, but not specified
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Mentioned as blinded, unclear who was blinded
Judgement Comment: Mentioned as double-blinded. Unclear who was blinded. The II period was open -label- however the III period was double blinded, placebo controlled trial.
Judgement Comment: Mentioned as double-blinded. Unclear who was blinded.
Judgement Comment: Mentioned as double blinded. Unclear who was blinded
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Quote:"Patients assigned to the placebo group received placebo twicedaily""Patients and site personnelwere informed of the 2-week placebo period, but were blinded to itstiming and duration; investigational review boards were provided arationale in a supplement to the protocol and informed of timingand duration. All of the investigational review boards and all of theinvestigators accepted this condition."
Judgement Comment: Nothing mentioned
Judgement Comment: Mentioned as blinded. Unclear who was blinded.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Insufficient information on blinding
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Quote: "In addition, both the site investiga- tors and subjects were blinded to the response criterion used in the initial trial and to when that phase ended and the next phase began. These design features all served to protect the blind during the crossover phase of the study."
Judgement Comment: Nothing mentioned
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
Judgement Comment: See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Quote: "In addition to pharmacotherapy, treatment in- cluded a psychoeducational program for the patients’ caregivers of both treatment groups."
Judgement Comment: Mentioned as blinded. Unclear who was blinded.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Mentioned as blinded. Unclear who was blinded.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: This is a randomized, double-blind, placebo-controlled, two-arm, multicenter study
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Nothing mentioned
Judgement Comment: Mentioned as blinded, but not specified Parents were blinded to the intervention and it is therefore reasonable to think that bias is balanced equally between the groups. However, this is self-reported outcomes.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: As this is a double-blinded study we can assume that bias is equal distributed and not a problem. - However this is self-reported meausrements Mentioned as blinded, unclear who was blinded
Judgement Comment: Mentioned as double-blinded. Unclear who was blinded Not clear if the outcome assessors were blined
Judgement Comment: Mentioned as double-blinded. Unclear who was blinded.
Judgement Comment: Insufficient information on blinding of the outcome assessors
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Mentioned as blinded. Unclear who was blinded.
Judgement Comment: Nothing mentioned
Judgement Comment: Mentioned as blinded. Unclear who was blinded.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Insufficient information on blinding
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Unclear if outcome assessors were blinded
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
Judgement Comment: See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Judgement Comment: Unclear if outcome assessors are blinded
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Insufficient information on blinding of the outcome assessors
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: This is a randomized, double-blind, placebo-controlled, two-arm, multicenter study
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Last-observation-carried-forward was used. No apparent sources of bias
Quote: "All statistical tests were performed using a 2-tailed, .05 signif- icance level using an intent-to-treat principle. Treatment"
Judgement Comment: No apparent sources of bias
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias 83% of the randomized children completed the study
Judgement Comment: No apparent sources of bias Only five participants discontinued after randomization and they use LOCF in their analyses
Judgement Comment: No difference between groups at baseline. However only 62.7% from the placebo groups completed the study. They do however conduct analyses to look at difference in dropout. No apparent sources of bias.
Judgement Comment: The analyses of effects were carried out by intention to treat. Single missing-item were imputed by the mean score of the remaining items when computing subscale and total score
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Last observation carried forward (LOCF) was used in the statistical analyses. No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias. low droupout
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Reason for missing outcome data was balanced accrossed groups No apparent sources of bias.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias conducts ITT
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
Judgement Comment: See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Judgement Comment: No apparent sources of bias. LOCF analyses
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Missing data replaced with last observation carried forward
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Information on attrition is provided, and reasons for exclusions given.Ittention to treat analysis were performed.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Reporting bias due to selective outcome reporting
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Selective reporting not suggested - however no protocol registered No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias No reason to suspect selective outcome reporting. Not reffering to a registered protocol
Judgement Comment: The study protocol has been registered in clinicaltrials.gov, identifier: NCT00191945.The protocol refers the following secondary outcomes, which was not reported in the present study:Vital Signs - Systolic Blood Pressure [ Time Frame: Baseline and 12 weeks ]Vital Signs - Diastolic Blood Pressure [ Time Frame: Baseline and 12 weeks ]Vital Signs - Pulse [ Time Frame: Baseline and 12 weeks ]Vital Signs - Weight [ Time Frame: Baseline and 12 weeks ]
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias.
Judgement Comment: Matches study protocol
Judgement Comment: No apparent sources of bias. No reason to suspect slective outcome reporting
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No reference to study protocol, but appears to be from selective outcome reporting
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
Judgement Comment: See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Judgement Comment: No apparent sources of bias.Not refering to a registered protocol
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: The study protocol was registered in clinicaltrials.gov (NCT00546910) and there was consistency in the reporting
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Study is registered in clinicaltrial.gov.There are no apperant risk of bias in relation to selective outcome reporting.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Bias due to problems not covered elsewhere in the table
Judgement Comment: No apparent sources of bias
Quote: "This research was funded by Eli Lilly and Company."
Judgement Comment: No apparent sources of bias
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias.
Judgement Comment: The study appears to be free from other sources of bias
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias.
Judgement Comment: No other apparent sources of bias
Judgement Comment: No other apparent sources of bias.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: The study appears to be free from other sources of bias
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: No apparent sources of bias.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: See Allen 2005 "Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders"
See Svanborg, P.; Thernlund, G.; Gustafsson, P. A.; Hagglof, B.; Poole, L.; Kadesjo, B. Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naive Swedish children and adolescentsEuropean child & adolescent psychiatry 2009;18(4):240-249 Germany 2009
Judgement Comment: No apparent sources of bias.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Financed by medcine industry and it is unclear which role the Funding had in the study. No apparent sources of bias.
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
Judgement Comment: Funding source has been reported and the study apparently seem free of other sources of bias
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017
See Joseph et al "Comparative efficacy and safety of attention-deficit/hyperactivity disorder pharmacotherapies, including guanfacine extended release: a mixed treatment comparison" 2017