Clinical trial NCT00734435: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: schizophrenia
schizophreniform
schizoaffective disorder
Zyprexa
olanzapine
Lead sponsor: Orexigen Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage change in total body weight
timeFrame: Baseline to Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Synergy Research
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: San Diego
country: United States
facility: CNRI San Diego
state: California
city: Bradenton
country: United States
facility: Florida Clincal Research Center
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Oak Brook
country: United States
facility: American Medical Research
state: Illinois
city: Indianapolis
country: United States
facility: Larue D. Carter Hospital
state: Indiana
city: Brooklyn
country: United States
facility: Brooklyn Medical Institute
state: New York
Study officials:
affiliation: Larue D. Carter Hospital
name: Alan Breier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Medical Research
name: Mohammed Alam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCI Medical Center
name: Gerald Maguire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooklyn Medical Institute
name: Zinoviy Benzar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Synergy Research
name: Mohammed Bari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CNRI
name: Tran Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Clinical Research Center, Maitland Florida
name: Eduard Gfeller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida Clinical Research Center, Bradenton Florida
name: Andrew Cutler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Center for Medical Research
name: Robert Riesenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: