Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects - Full Text View

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

MedlinePlus related topics:

Psychotic Disorders Schizophrenia

ChemIDplus related topics:

Olanzapine Zonisamide

U.S. FDA Resources

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

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 ]

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	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	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

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

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

Keywords provided by Orexigen Therapeutics, Inc:

schizophrenia

schizophreniform

schizoaffective disorder

Zyprexa

olanzapine

Study placed in the following topic categories:

Schizophrenia

Body Weight

Signs and Symptoms

Mental Disorders

Zonisamide

Olanzapine

Body Weight Changes

Psychotic Disorders

Weight Gain

Serotonin

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Disease

Antioxidants

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Psychotropic Drugs

Antiemetics

Central Nervous System Depressants

Antipsychotic Agents

Serotonin Uptake Inhibitors

Protective Agents

Pharmacologic Actions

Serotonin Agents

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on October 14, 2008

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