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

This study has been completed.
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141479
First received: August 30, 2005
Last updated: May 5, 2006
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Bifeprunox
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141479

Locations
United States, Kansas
Site 1
Wichita, Kansas, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141479     History of Changes
Other Study ID Numbers: S154.2.013
Study First Received: August 30, 2005
Last Updated: May 5, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Treatment interruption on reinitiation
Schizophrenia
Schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014