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NCT00141479 Clinical Trial

To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox

Schizophrenia Clinical Trial

Official title:
A Single-center Safety and Tolerability Study to Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141479
Other study ID # S154.2.013
Secondary ID
Status Completed
Phase Phase 2
First received August 30, 2005
Last updated January 15, 2015
Start date May 2005
Est. completion date November 2006

Study information
Verified date May 2006
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Diagnosis of Schizophrenia or Schizoaffective disorder

- 18-55 years

Exclusion Criteria:

- Subjects who are acutely psychotic

- Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia

- Subjects at significant risk of suicide

- Subjects with a seizure disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bifeprunox

Locations
Country Name City State
United States Site 1 Wichita Kansas

Sponsors (3)
Lead Sponsor Collaborator
Solvay Pharmaceuticals H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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