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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

August 12, 2008
November 27, 2012
September 2008
December 2008   (final data collection date for primary outcome measure)
Percentage change in total body weight [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734435 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
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)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734435
OZ-101
No
Orexigen Therapeutics, Inc
Orexigen Therapeutics, Inc
Not Provided
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
Orexigen Therapeutics, Inc
November 2012

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