Back to resultsProgressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bifeprunox
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Decreasing Titration Study, Schizophrenia, Bipolar, Pharmacokinetic
Eligibility Criteria
Inclusion Criteria: Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria Age 18 to 55 Body weight 100-250 lbs Be sufficiently stable to allow discontinuation of antipsychotic medication Exclusion Criteria: Acutely psychotic subjects Subjects that are acutely manic Subjects with a psych diagnosis other than Bipolar Type I Disorder
Sites / Locations
- Site 1
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00139919
First Posted
August 30, 2005
Last Updated
January 15, 2015
Sponsor
Solvay Pharmaceuticals
Collaborators
H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00139919
Brief Title
Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study of the Safety and Tolerability of Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Either Schizophrenia or Bipolar Disorder With an Optional Open-Label 26-Week Extension Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
Collaborators
H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Keywords
Decreasing Titration Study, Schizophrenia, Bipolar, Pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bifeprunox
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
Age 18 to 55
Body weight 100-250 lbs
Be sufficiently stable to allow discontinuation of antipsychotic medication
Exclusion Criteria:
Acutely psychotic subjects
Subjects that are acutely manic
Subjects with a psych diagnosis other than Bipolar Type I Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Orange
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
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