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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00141479
First Posted: September 1, 2005
Last Update Posted: January 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
  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
Intervention Model: Single Group Assignment
Masking: Double
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00141479     History of Changes
Other Study ID Numbers: S154.2.013
First Submitted: August 30, 2005
First Posted: September 1, 2005
Last Update Posted: January 16, 2015
Last Verified: May 2006

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

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders