NCT00734435

Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects

A Proof of Concept, Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled, Study of Zonisamide Sustained Release (SR) 360 mg Versus Placebo in the Prevention of Weight Gain Associated With Olanzapine Therapy for Psychosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder

Interventions

Type	Name	Description
DRUG	zonisamide SR plus olanzapine	zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)
DRUG	Placebo plus olanzapine	Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-08-14
• Last updated: 2012-11-29

Locations

9 sites across 1 country: United States