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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

In brief

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

Key facts

Study ID

NCT00734435

Run by

Orexigen Therapeutics, Inc

People needed

26

Starts

2008-09-01

Expected to finish

2008-12-01

Last updated by the study team

2012-11-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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