Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

Phase 2

Withdrawn

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: PNU-165442G; [S,S]-reboxetine; Drug: Atomoxetine

• Registration Number: NCT00562055
• Lead Sponsor: Pfizer

Brief Summary

This study will compare the safety and efficacy of \[S,S\]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria.
2. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale
3. Score of 4 or higher on the Clinician Global Impression - Severity scale

Exclusion Criteria

1. Significant comorbid psychiatric diagnoses
2. Significant risk of suicidal or violent behavior

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	PNU-165442G; [S,S]-reboxetine	-
Arm B	Atomoxetine	-

Primary Outcome Measures

Name	Time	Method
Adult ADHD Investigator Symptom Rating Scale - Total Score	4 weeks

Secondary Outcome Measures

Name	Time	Method
Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score	4 weeks
Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score	4 weeks