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
  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 2

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


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
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 Name: 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 Name: Zyprexa

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Synergy Research
National City, California, United States, 91950
UCI Medical Center
Orange, California, United States, 92868
CNRI San Diego
San Diego, California, United States, 92126
United States, Florida
Florida Clincal Research Center
Bradenton, Florida, United States, 34208
Florida Clinical Research Center
Maitland, 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
ClinicalTrials.gov Identifier: NCT00734435     History of Changes
Other Study ID Numbers: OZ-101
Study First Received: August 12, 2008
Last Updated: November 27, 2012
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:
Psychotic Disorders
Schizophrenia
Weight Gain
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
Zonisamide
Olanzapine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 20, 2014