Schizophrenia
Conditions
Keywords
Schizophrenia, weight changes
Brief summary
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.
Interventions
DRUGBifeprunox
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.
DRUGQuetiapine
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.
Sponsors
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Solvay Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Triglyceride | 8 weeks |
| Detorioration (composite definition using PANSS total score and CGI-I) | 26 weeks |
| Change from baseline in Weight, Triglyceride and Cardiovascular risk factors | 52 weeks |
Countries
Argentina, Canada, Chile, Czechia, Estonia, Finland, Germany, Hungary, Latvia, Lithuania, Peru, Slovakia, South Africa, United States
Outcome results
None listed