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

November 27, 2012 updated by: Orexigen Therapeutics, Inc

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • National City, California, United States, 91950
        • Synergy Research
      • Orange, California, United States, 92868
        • UCI Medical Center
      • San Diego, California, United States, 92126
        • CNRI San Diego
    • Florida
      • Bradenton, Florida, United States, 34208
        • Florida Clincal Research Center
      • Maitland, Florida, United States, 34208
        • Florida Clinical Research Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • American Medical Research
    • Indiana
      • Indianapolis, Indiana, United States, 46222
        • Larue D. Carter Hospital
    • New York
      • Brooklyn, New York, United States, 11223
        • Brooklyn Medical Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Zyprexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change in total body weight
Time Frame: Baseline to Week 16
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

August 12, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

November 29, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OZ-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on zonisamide SR plus olanzapine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe