Status:
COMPLETED
A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
Lead Sponsor:
Lindner Center of HOPE
Collaborating Sponsors:
Eli Lilly and Company
University of Cincinnati
Conditions:
Weight Gain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for psychotic or bipola...
Detailed Description
This is a single center, 16-week, randomized, double-blind, placebo-controlled, parallel group, flexible-dose study in 60 outpatients with schizophrenia, schizoaffective disorder, schizophreniform dis...
Eligibility Criteria
Inclusion
- Criteria for entering this study will include all of the following:
- Subjects must be 18 years of age or older.
- Subjects must have schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, psychotic disorder NOS, or bipolar I, II, or NOS disorder as defined by DSM-IV-TR criteria.
- Subjects must have a BMI \> 22.
- Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained.
- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, intrauterine device) for at least one month prior to study entry and throughout the study.
- If exposed to olanzapine in the past, subjects must be free of olanzapine for \> 3 months prior to randomization to study medication.
Exclusion
- Criteria for exclusion from this study will be any of the following:
- Subjects with clinically significant suicidal or homicidal ideation.
- Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a psychotic or mood disorder secondary to substance use or a general medical disorder; or a DSM-IV diagnosis of a substance use disorder within the past six months.
- Cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement \> 3 months.
- Subjects who are allergic to or who have demonstrated hypersensitivity to or significant adverse event from olanzapine.
- Subjects who are allergic to or who have demonstrated hypersensitivity to zonisamide.
- Women who are pregnant or nursing.
- Subjects who have received an experimental drug or used an experimental device within 30 days.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00363376
Start Date
January 1 2008
End Date
February 1 2011
Last Update
April 13 2012
Active Locations (1)
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1
The Lindner Center of HOPE
Mason, Ohio, United States, 45040