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Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia

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:
NCT00139906
First received: August 30, 2005
Last updated: March 7, 2006
Last verified: March 2006
History of Changes
  Purpose

This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.


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 Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: August 2005
  Eligibility

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

Inclusion Criteria:

  • Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
  • Body weight of 100-250 lbs
  • Male or females
  • 18-55 years of age

Exclusion Criteria:

  • Subjects who are acutely psychotic
  • Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139906

Locations
United States, California
Site 1
National City, California, 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: NCT00139906     History of Changes
Other Study ID Numbers: S154.2.016
Study First Received: August 30, 2005
Last Updated: March 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Titration Study
Schizophrenia
BID dosing
Pharmacokinetic

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

ClinicalTrials.gov processed this record on May 16, 2013