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Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT00734435•Orexigen Therapeutics, Inc

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (9)

Synergy Research

National City, California, United States

UCI Medical Center

Orange, California, United States

CNRI San Diego

San Diego, California, United States

Florida Clincal Research Center

Bradenton, Florida, United States

Florida Clinical Research Center

Maitland, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

American Medical Research

Oak Brook, Illinois, United States

Larue D. Carter Hospital

Indianapolis, Indiana, United States

Brooklyn Medical Institute

Brooklyn, New York, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

November 29, 2012

Enrollment

ACTUAL participants

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorder

Interventions

zonisamide SR plus olanzapine

DRUG

Placebo plus olanzapine

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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