Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients
This study has been terminated.
(This trial discontinued on 2 May 2008 due to lack of enrolment)
Sponsor:
Solvay Pharmaceuticals
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00396214
First received: November 3, 2006
Last updated: May 30, 2008
Last verified: May 2008
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Purpose
The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Bifeprunox Drug: Quetiapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients |
Resource links provided by NLM:
Further study details as provided by Solvay Pharmaceuticals:
Primary Outcome Measures:
- Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline in Triglyceride [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 83 |
| Study Start Date: | April 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Bifeprunox
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
|
| Experimental: 2 |
Drug: Bifeprunox
52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
|
| Active Comparator: 3 |
Drug: Quetiapine
Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Schizophrenia
- 18-65 years
- No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period
Exclusion Criteria:
- Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
- At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396214
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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
| Responsible Party: | Loretta Stallings, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00396214 History of Changes |
| Other Study ID Numbers: | S154.3.021, 2006-004973-83 |
| Study First Received: | November 3, 2006 |
| Last Updated: | May 30, 2008 |
| Health Authority: | United States: Food and Drug Administration Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Poland: Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Slovakia: State Institute for Drug Control |
Keywords provided by Solvay Pharmaceuticals:
|
Schizophrenia weight changes |
Additional relevant MeSH terms:
|
Body Weight Changes Schizophrenia Body Weight Signs and Symptoms Schizophrenia and Disorders with Psychotic Features Mental Disorders Quetiapine Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 16, 2013