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

NCT00734435 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-11-29

No results posted yet for this study

Summary

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

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder

Interventions

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)

DRUG

Placebo plus olanzapine

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

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Alan Breier, MD · Larue D. Carter Hospital

  • Mohammed Alam, MD · American Medical Research

  • Gerald Maguire, MD · UCI Medical Center

  • Zinoviy Benzar, MD · Brooklyn Medical Institute

  • Mohammed Bari, MD · Synergy Research

  • Tran Johnson, MD · CNRI

  • Eduard Gfeller, MD · Florida Clinical Research Center, Maitland Florida

  • Andrew Cutler, MD · Florida Clinical Research Center, Bradenton Florida

  • Robert Riesenberg, MD · Atlanta Center for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00734435 on ClinicalTrials.gov