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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00734435
Recruitment Status : Terminated (Sponsor Decision- Financial Considerations)
First Posted : August 14, 2008
Last Update Posted : November 29, 2012
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Drug: zonisamide SR plus olanzapine Drug: Placebo plus olanzapine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: 1
Zonisamide SR 360 mg and olanzapine 10-20 mg daily
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)
Other Name: Zyprexa

Placebo Comparator: 2
Placebo and olanzapine 10-20 mg daily
Drug: Placebo plus olanzapine
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)
Other Name: Zyprexa

Primary Outcome Measures :
  1. Percentage change in total body weight [ Time Frame: Baseline to Week 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00734435

United States, California
Synergy Research
National City, California, United States, 91950
UCI Medical Center
Orange, California, United States, 92868
CNRI San Diego
San Diego, California, United States, 92126
United States, Florida
Florida Clincal Research Center
Bradenton, Florida, United States, 34208
Florida Clinical Research Center
Maitland, Florida, United States, 34208
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
American Medical Research
Oak Brook, Illinois, United States, 60523
United States, Indiana
Larue D. Carter Hospital
Indianapolis, Indiana, United States, 46222
United States, New York
Brooklyn Medical Institute
Brooklyn, New York, United States, 11223
Sponsors and Collaborators
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 Identifier: NCT00734435     History of Changes
Other Study ID Numbers: OZ-101
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Orexigen Therapeutics, Inc:
schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Weight Gain
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Protective Agents