[Summary text]
Randomized, double-blinded, placebo-controlled, multi-site trial.
Adult patients, 18–65-years old, meeting the DSM-IV-TR diagnoses for both ADHD and social anxiety disorder, were enrolled. The diagnostic criteria for ADHD were assessed with the Conners’ Adult ADHD Diagnostic Interview for DSM-IV and for social anxiety disorder by the Structured Clinical Interview for DSM-IVTR Axis I Disorders-Research Version. Additionally, patients had an LSAS Total score of at least 50 at Visit 1, no more than a 30%
decrease in LSAS Total score at Visit 2, and a Clinical Global Impression-Overall-Severity (CGI-O-S) score of 4 or greater at Visits 1 and 2. Concomitant Axis I diagnoses (current or lifetime)-specific phobias, Generalized Anxiety Disorder (GAD), and dysthymia were allowed. Current diagnosis of major depressive disorder was allowed only if diagnosed more than 6 months before Visit 1. Exclusionary criteria included current or lifetime diagnosis of
obsessive–compulsive disorder, bipolar affective disorder, psychosis, factitious disorder, or somatoform disorders, and/or current diagnosis of panic disorder, posttraumatic stress disorder, or an eating alcohol, drugs of abuse, or prescription medication abuse meeting DSM-IV-TR criteria were also excluded.
PBO 2 weeks and then ATX 14 weeks
ADHD symptoms, social anxiety, function,QoL, adverse events
Ref ID 1615
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Computer algorithm that blindly assigned patients to ATX or PBO 1:1
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
locked database
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Double-blinded
Detection bias due to knowledge of the allocated interventions by outcome assessors
Double-blinded
Attrition bias due to amount, nature or handling of incomplete outcome data
Drop out high but are described
Reporting bias due to selective outcome reporting
None detected
Bias due to problems not covered elsewhere in the table
None detected