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

This study has been terminated.

(Sponsor Decision- Financial Considerations)

Sponsor:

Information provided by (Responsible Party):

Orexigen Therapeutics, Inc

ClinicalTrials.gov Identifier:

NCT00734435

First received: August 12, 2008

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2008

Last Updated Date

November 27, 2012

Start Date ^ICMJE

September 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00734435 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Intervention ^ICMJE

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
Drug: Placebo plus olanzapine
Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period)

Other Name: Zyprexa

Study Arm (s)

Active Comparator: 1
Zonisamide SR 360 mg and olanzapine 10-20 mg daily

Intervention: Drug: zonisamide SR plus olanzapine
Placebo Comparator: 2
Placebo and olanzapine 10-20 mg daily

Intervention: Drug: Placebo plus olanzapine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00734435

Other Study ID Numbers ^ICMJE

OZ-101

Has Data Monitoring Committee

Responsible Party

Orexigen Therapeutics, Inc

Study Sponsor ^ICMJE

Orexigen Therapeutics, Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Orexigen Therapeutics, Inc

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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