Status:
COMPLETED
Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Lead Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Collaborating Sponsors:
Eisai Inc.
Conditions:
Obesity
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index ...
Detailed Description
After the screening period, patients fulfilling entrance criteria will be randomized to 100mg of zonisamide or placebo in a 2:1 ratio respectively. Patients will be assessed at baseline and on Weeks 2...
Eligibility Criteria
Inclusion
- Are men or women, between the ages of 19 and 65, inclusive
- Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI).
- Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months.
- Have a body mass index \> 25.
- No substance use disorder in the past 2 months (except for nicotine or caffeine).
- Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication.
- Are able to swallow the capsules whole
- Are willing and able to follow Investigator instructions and study procedures, and report adverse events
- Not currently actively suicidal or homicidal.
- No use of topiramate within the last 6 months.
- No medical contraindication to the use of zonisamide.
- List of medications for inclusion criterion #3:
- All conventional neuroleptics. All atypical neuroleptics except aripiprazole or ziprasidone. All forms of valproate. All forms of lithium. All forms of carbamazepine.
Exclusion
- Clinically significant renal or hepatic disease.
- History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia.
- Allergy to zonisamide or sulfonamides.
- Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease
- Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities
- Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug
- Are pregnant or lactating (females only)
- Have a history of nephrolithiasis
- Refuse to give informed consent
- Have previously enrolled in this study or previously been treated with zonisamide
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00203450
Start Date
May 1 2003
End Date
March 1 2006
Last Update
September 3 2012
Active Locations (1)
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Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404