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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00734435

Enrollment

Registered

2008-08-14

Start date

2008-09-30

Completion date

2008-12-31

Last updated

2012-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder

Keywords

schizophrenia, schizophreniform, schizoaffective disorder, Zyprexa, olanzapine

Brief summary

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

Interventions

DRUGzonisamide SR plus olanzapine

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

DRUGPlacebo plus olanzapine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
Percentage change in total body weight	Baseline to Week 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026