Trial | NCT00734435  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    olanzapine zonisamide ...

  • Study Participants

    26
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
Study Started
Sep 30
2008
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Nov 29
2012
Estimate

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 names: Zyprexa

Drug Placebo plus olanzapine

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

  • Other names: Zyprexa

1 Active Comparator

Zonisamide SR 360 mg and olanzapine 10-20 mg daily

2 Placebo Comparator

Placebo and olanzapine 10-20 mg daily

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
No Results Posted