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Sponsored by: |
Orexigen Therapeutics, Inc |
Information provided by: | Orexigen Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00734435 |
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
Condition | Intervention | Phase |
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: zonisamide SR plus olanzapine Drug: Placebo plus olanzapine |
Phase II |
MedlinePlus related topics: | Psychotic Disorders Schizophrenia |
ChemIDplus related topics: | Olanzapine Zonisamide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 75 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Zonisamide SR 360 mg and olanzapine 10-20 mg daily
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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)
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2: Placebo Comparator
Placebo and olanzapine 10-20 mg daily
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Drug: Placebo plus olanzapine
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Synergy Research | Recruiting | ||||
National City, California, United States, 91950 | |||||
Contact: Shawna Blackmun 888-619-7572 blackmuns@synergysandiego.com | |||||
Principal Investigator: Mohammed Bari, MD | |||||
CNRI San Diego | Recruiting | ||||
San Diego, California, United States, 92126 | |||||
Contact: Tran Johnson, MD 858-566-8222 CNRI@pacbell.net | |||||
Principal Investigator: Tran Johnson, MD | |||||
UCI Medical Center | Not yet recruiting | ||||
Orange, California, United States, 92868 | |||||
Contact: Inee Byun 714-456-3489 ibyun@uci.edu | |||||
Principal Investigator: Gerald Maguire, MD | |||||
United States, Florida | |||||
Florida Clinical Research Center | Recruiting | ||||
Maitland, Florida, United States, 34208 | |||||
Contact: Theresa Harden 941-782-4628 tharden@flcrc.com | |||||
Principal Investigator: Eduard Gfeller, MD | |||||
Florida Clincal Research Center | Recruiting | ||||
Bradenton, Florida, United States, 34208 | |||||
Contact: Gilbert De la Cruz 407-644-1165 gdelacruz@coreresearch.com | |||||
Principal Investigator: Andrew Cutler, MD | |||||
United States, Georgia | |||||
Atlanta Center for Medical Research | Recruiting | ||||
Atlanta, Georgia, United States, 30308 | |||||
Contact: Kelly Calistri 404-881-5800 kcalistri@acmr.org | |||||
Principal Investigator: Robert Riesenberg, MD | |||||
United States, Illinois | |||||
American Medical Research | Recruiting | ||||
Oak Brook, Illinois, United States, 60523 | |||||
Contact: Linda Zusevics 630-928-1000 lindaz@americanmedicalresearch.com | |||||
Principal Investigator: Mohammed Alam, MD | |||||
United States, Indiana | |||||
Larue D. Carter Hospital | Not yet recruiting | ||||
Indianapolis, Indiana, United States, 46222 | |||||
Contact: Amy Frazer 317-941-4275 aefrazer@iupui.edu | |||||
Principal Investigator: Alan Breier, MD | |||||
United States, New York | |||||
Brooklyn Medical Institute | Recruiting | ||||
Brooklyn, New York, United States, 11223 | |||||
Contact: Polina Sadkovets 718-456-3489 psadkovets@gminstitutes.com | |||||
Principal Investigator: Zinoviy Benzar, MD |
Orexigen Therapeutics, Inc |
Principal Investigator: | Alan Breier, MD | Larue D. Carter Hospital |
Principal Investigator: | Mohammed Alam, MD | American Medical Research |
Principal Investigator: | Gerald Maguire, MD | UCI Medical Center |
Principal Investigator: | Zinoviy Benzar, MD | Brooklyn Medical Institute |
Principal Investigator: | Mohammed Bari, MD | Synergy Research |
Principal Investigator: | Tran Johnson, MD | CNRI |
Principal Investigator: | Eduard Gfeller, MD | Florida Clinical Research Center, Maitland Florida |
Principal Investigator: | Andrew Cutler, MD | Florida Clinical Research Center, Bradenton Florida |
Principal Investigator: | Robert Riesenberg, MD | Atlanta Center for Medical Research |
Responsible Party: | Orexigen Therapeutics, Inc. ( Dr. Ronald Landbloom ) |
Study ID Numbers: | OZ-101 |
First Received: | August 12, 2008 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00734435 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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