Back to resultsTwice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective 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 Titration Study, Schizophrenia, BID dosing, Pharmacokinetic
Eligibility 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
Sites / Locations
- Site 1
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00139906
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
NCT00139906
Brief Title
Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Titration Study, Schizophrenia, BID dosing, 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 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
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
National City
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia
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