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

Phase 2

Terminated

• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Interventions: Drug: zonisamide SR plus olanzapine; Drug: Placebo plus olanzapine

• Registration Number: NCT00734435
• Lead Sponsor: Orexigen Therapeutics, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Start: 2008-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	zonisamide SR plus olanzapine	Zonisamide SR 360 mg and olanzapine 10-20 mg daily
2	Placebo plus olanzapine	Placebo and olanzapine 10-20 mg daily

Primary Outcome Measures

Name	Time	Method
Percentage change in total body weight	Baseline to Week 16

Trial Locations

Locations (9)

Florida Clinical Research Center; 🇺🇸 Maitland, Florida, United States

UCI Medical Center; 🇺🇸 Orange, California, United States

Synergy Research; 🇺🇸 National City, California, United States

CNRI San Diego; 🇺🇸 San Diego, California, United States

Florida Clincal Research Center; 🇺🇸 Bradenton, 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