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

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NCT00141479

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Study Location
Site 1
Wichita, Kansas, , United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Schizoaffective Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of Schizophrenia or Schizoaffective disorder

- 18-55 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE Drug: Bifeprunox
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00141479
Other Study ID Numbers  ICMJE S154.2.013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE
  • H. Lundbeck A/S
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:Global Clinical Director SolvaySolvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP