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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

zonisamide SR plus olanzapine

Placebo plus olanzapine

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizophreniform, schizoaffective disorder, Zyprexa, olanzapine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Zonisamide SR 360 mg and olanzapine 10-20 mg daily

Placebo and olanzapine 10-20 mg daily

Outcomes

Primary Outcome Measures

Percentage change in total body weight

Secondary Outcome Measures

Full Information

NCT ID

NCT00734435

First Posted

August 12, 2008

Last Updated

November 27, 2012

Sponsor

Orexigen Therapeutics, Inc

1. Study Identification

Unique Protocol Identification Number

NCT00734435

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor Decision- Financial Considerations

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Orexigen Therapeutics, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Keywords

schizophrenia, schizophreniform, schizoaffective disorder, Zyprexa, olanzapine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Zonisamide SR 360 mg and olanzapine 10-20 mg daily

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo and olanzapine 10-20 mg daily

Intervention Type

Drug

Intervention Name(s)

zonisamide SR plus olanzapine

Other Intervention Name(s)

Zyprexa

Intervention Description

zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period)

Intervention Type

Drug

Intervention Name(s)

Placebo plus olanzapine

Other Intervention Name(s)

Zyprexa

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage change in total body weight

Time Frame

Baseline to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: