Back to resultsTo Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
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 Treatment interruption on reinitiation, Schizophrenia, Schizoaffective disorder
Eligibility 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
Sites / Locations
- Site 1
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00141479
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
NCT00141479
Brief Title
To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Treatment interruption on reinitiation, Schizophrenia, Schizoaffective disorder
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:
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
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
Wichita
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
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