Status:
TERMINATED
Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
Lead Sponsor:
Orexigen Therapeutics, Inc
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00734435
Start Date
September 1 2008
End Date
December 1 2008
Last Update
November 29 2012
Active Locations (9)
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1
Synergy Research
National City, California, United States, 91950
2
UCI Medical Center
Orange, California, United States, 92868
3
CNRI San Diego
San Diego, California, United States, 92126
4
Florida Clincal Research Center
Bradenton, Florida, United States, 34208