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NCT00562055 Clinical Trial

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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:
Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00562055
Other study ID # A6061060
Secondary ID A6061060
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date November 2007

Study information
Verified date April 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Disease
  • Hyperkinesis

Intervention

Drug:
• Atomoxetine

• PNU-165442G; [S,S]-reboxetine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Adult ADHD Investigator Symptom Rating Scale - Total Score 4 weeks
Secondary Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score 4 weeks
Secondary Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score 4 weeks
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