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

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