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

This study has been completed.
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: August 30, 2005
Last updated: January 15, 2015
Last verified: May 2006
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
Schizoaffective Disorder
Drug: Bifeprunox
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00141479

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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information Identifier: NCT00141479     History of Changes
Other Study ID Numbers: S154.2.013
Study First Received: August 30, 2005
Last Updated: January 15, 2015

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

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 22, 2017