Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
Overview
Determine if there is a difference in treatment response for adults with ADHD who are treated with Strattera versus those treated with a combination of Strattera and buspirone
Full Title of Study: “Eight-Week, Double-Blind, 3-Arm Parallel, Placebo-Controlled, Randomized Efficacy And Safety Trial Of Atomoxetine, Atomoxetine Plus Buspirone, And Placebo In Adults With Attention Deficit Hyperactivity Disorder”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
Interventions
- Drug: Atomoxetine
- Drug: Buspirone
Clinical Trial Outcome Measures
Primary Measures
- To assess the efficacy of Atomoxetine-Buspirone (ATX-BSP) vs placebo (PBO) and atomoxetine (ATX) monotherapy in adult patients with ADHD as measured by the mean change across 7 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
Secondary Measures
- To characterize the safety over 8 weeks of ATX-BSP as compared to PBO and ATX monotherapy. To assess the response rate for the 3 treatment groups based on AISRS and CGI scores.
Participating in This Clinical Trial
Inclusion Criteria
- Adults with ADHD Exclusion Criteria:
- Other Axis I Psychiatric Disorders
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Pfizer
- Overall Official(s)
- Pfizer CT.gov Call Center, Study Director, Pfizer
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