At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of SPD489 on Executive Function (Self-Regulation) Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Reporting Clinically Significant Impairment of Real-World Executive Function Behavior.
In Brief
A Phase 4 clinical trial evaluating SPD489 and Placebo for ADHD Specifically With Executive Function Impairment. Completed, enrolled 161 participants across 39 sites.
Detailed Summary
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.
Study Details
Timeline
Interventions
1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks)
1 capsule per day, daily throughout the double-blind treatment period (10 weeks)