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

This study has been terminated.

( Sponsor Decision- Financial Considerations )

First Received: August 12, 2008 Last Updated: February 4, 2010 History of Changes

Sponsor:	Orexigen Therapeutics, Inc
Information provided by:	Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00734435

Purpose

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

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

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Zonisamide Olanzapine

U.S. FDA Resources

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:

Percentage change in total body weight [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

Enrollment:	26
Study Start Date:	September 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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)
2: Placebo Comparator 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)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734435

Locations

United States, California
Synergy Research
National City, California, United States, 91950
CNRI San Diego
San Diego, California, United States, 92126
UCI Medical Center
Orange, California, United States, 92868
United States, Florida
Florida Clinical Research Center
Maitland, Florida, United States, 34208
Florida Clincal Research Center
Bradenton, 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

Investigators

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

More Information

No publications provided

Responsible Party:	Orexigen Therapeutics, Inc. ( Dr. Ronald Landbloom )
Study ID Numbers:	OZ-101
Study First Received:	August 12, 2008
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00734435 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Orexigen Therapeutics, Inc:

schizophrenia
schizophreniform
schizoaffective disorder
Zyprexa
olanzapine

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Body Weight
Schizophrenia
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Body Weight Changes

Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Disease
Tranquilizing Agents
Zonisamide
Gastrointestinal Agents
Central Nervous System Depressants
Weight Gain
Antipsychotic Agents
Protective Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010