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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Zonisamide SR 360 mg and olanzapine 10-20 mg daily
• Placebo Comparator: 2
  • Placebo and olanzapine 10-20 mg daily

Primary Measures

• Percentage change in total body weight
  • Time Frame: Baseline to Week 16
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Orexigen Therapeutics, Inc

Overall Clinical Trial Officials and Contacts

Alan Breier, MD Principal Investigator Larue D. Carter Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00734435

Study ID Number: OZ-101

ClinicalTrials.gov Identifier: NCT00734435

Health Authority: United States: Food and Drug Administration