Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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 (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Collaborator: Eisai Inc.
• Treatments: Psychotropic Drugs; Zonisamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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