Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
NCT ID: NCT00734435
Last Updated: 2012-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
26 participants
INTERVENTIONAL
2008-09-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Zonisamide SR 360 mg and olanzapine 10-20 mg daily
zonisamide SR plus olanzapine
zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)
2
Placebo and olanzapine 10-20 mg daily
Placebo plus olanzapine
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
Interventions
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zonisamide SR plus olanzapine
zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)
Placebo plus olanzapine
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
No
Sponsors
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Orexigen Therapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Breier, MD
Role: PRINCIPAL_INVESTIGATOR
Larue D. Carter Hospital
Mohammed Alam, MD
Role: PRINCIPAL_INVESTIGATOR
American Medical Research
Gerald Maguire, MD
Role: PRINCIPAL_INVESTIGATOR
UCI Medical Center
Zinoviy Benzar, MD
Role: PRINCIPAL_INVESTIGATOR
Brooklyn Medical Institute
Mohammed Bari, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Research
Tran Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
CNRI
Eduard Gfeller, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Clinical Research Center, Maitland Florida
Andrew Cutler, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Clinical Research Center, Bradenton Florida
Robert Riesenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta Center for Medical Research
Locations
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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
Countries
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Other Identifiers
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OZ-101
Identifier Type: -
Identifier Source: org_study_id