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Zonisamide SR for Olanzapine-Associated Weight Gain
NCT00734435Phase 2
Key facts
- Status
- Terminated
- Start
- Sep 2008
- Primary completion
- Dec 2008
- Countries
- 1
- Sponsor
- Orexigen Therapeutics
- Modality
- Small Molecules
- Drugs
- zonisamide
01
Overview
Phase 2, randomised, double-blind trial comparing Zonisamide SR + Olanzapine with Placebo + Olanzapine (2 arms). Primary endpoint: Percentage change in total body weight at 16 weeks. Started Sep 2008; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Zonisamide SR + Olanzapine
Zonisamide SR (titrated to max 600 mg) + Olanzapine (10-20 mg)
Placebo + Olanzapine
Placebo + Olanzapine (10-20 mg)
03
Who it enrols
Adult outpatients with schizophrenia, schizoaffective disorder, or schizophreniform disorder, BMI 22-35, requiring a change in antipsychotic treatment where olanzapine is appropriate.
04
Endpoints
Primary
Percentage change in total body weight
Secondary
Change in body weight
Proportion of patients gaining >= 7% body weight
Change in Body Mass Index
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