At a glance
ClinicalIndex Comparison Record- ✓Meet DSM-IV-TR criteria for Adult ADHD as assessed by Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID)
- ✓CGI-ADHD-S score of 4 or greater at Visits 2 and 3
- ✓Age 18 years or older
- ✓In a reciprocal relationship with opposite-sex partner, cohabiting for ≥3 months
- ✕Any history of bipolar disorder or psychotic disorder
- ✕Current major depression or current anxiety disorder
- ✕Regular use of psychotropic medications
- ✕Any medical condition that would be exacerbated or inappropriate for trial inclusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder: With a Secondary Examination of Impact of Treatment on Family Functioning
In Brief
A Phase 4 clinical trial evaluating Atomoxetine Hydrochloride and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 502 participants across 21 sites in 2 countries.
Detailed Summary
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.
Study Details
Timeline
Interventions
Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.