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

Completed · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00203450

Run by

Tuscaloosa Research & Education Advancement Corporation

People needed

20

Starts

2003-05-01

Expected to finish

2006-03-01

Last updated by the study team

2012-09-03

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tuscaloosa Research & Education Advancement Corporation — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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