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

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

Official Title
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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

Conditions
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Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Intervention / Treatment
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* Drug: zonisamide SR plus olanzapine
* Drug: Placebo plus olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects,18-55 years of age Outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder Body mass index (BMI) between 22-35 kg/m2 (inclusive) Negative serum pregnancy test in women of child-bearing potential If women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug Subject requires a change in antipsychotic treatment and olanzapine is deemed by the Investigator to be a reasonable antipsychotic treatment choice No clinically significant abnormality on ECG No clinically significant laboratory abnormality Negative urine drug screen Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule Must be able to read and understand English Exclusion Criteria: Diagnosis of substance dependence within the 6 months prior to randomization diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization Suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent Presence of dementia or other organic brain syndrome Serious or unstable medical illnesses Known, uncorrected narrow-angle glaucoma Diagnosis of eating disorder as defined by DSM-IV within 6 months prior to randomization Require treatment with any typical or atypical antipsychotic in addition to olanzapine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Zonisamide SR 360 mg and olanzapine 10-20 mg daily | Drug: zonisamide SR plus olanzapine<br>* zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)<br>* Other names: Zyprexa;|
| Placebo Comparator: 2<br>Placebo and olanzapine 10-20 mg daily | Drug: Placebo plus olanzapine<br>* Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)<br>* Other names: Zyprexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in total body weight |  | Baseline to Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, schizophreniform, schizoaffective disorder, Zyprexa, olanzapine