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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00734435
• Other study ID #: OZ-101
• Status: Terminated
• Phase: Phase 2
• First received: August 12, 2008
• Last updated: November 27, 2012
• Start date: September 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2012
• Source: Orexigen Therapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Florida Clincal Research Center	Bradenton	Florida
United States	Brooklyn Medical Institute	Brooklyn	New York
United States	Larue D. Carter Hospital	Indianapolis	Indiana
United States	Florida Clinical Research Center	Maitland	Florida
United States	Synergy Research	National City	California
United States	American Medical Research	Oak Brook	Illinois
United States	UCI Medical Center	Orange	California
United States	CNRI San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Orexigen Therapeutics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in total body weight		Baseline to Week 16	No