Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Information source: Tuscaloosa Research & Education Advancement Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: zonisamide (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Tuscaloosa Research & Education Advancement Corporation
Official(s) and/or principal investigator(s):
Lori L Davis, MD, Principal Investigator, Affiliation: Tuscaloosa VA Medical Center
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
Official title: Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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
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, 4, 8, 12, and 16-post randomization for weight, side effects, and symptoms.
Symptoms will be assessed by the Young Mania Rating Scale (YMRS), Brief Psychiatric Rating
Scale (BPRS), Hamilton Depression Rating Scale (HAMD), Hamilton Rating Scale for Anxiety
(HARS), and Self-report measures of general health and mental status at baseline, weeks 2, 4,
8, 12,and 16. At the conclusion of the study, patients will be tapered from the study
medication and will return to their primary provider for continued treatment of their
Minimum age: 19 Years.
Maximum age: 65 Years.
- 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
- 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.
- 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
- 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
Locations and Contacts
Tuscaloosa Research & Education Advancement Corporation, Tuscaloosa, Alabama 35404, United States
Appolinario JC, Bueno JR, Coutinho W. Psychotropic drugs in the treatment of obesity: what promise? CNS Drugs. 2004;18(10):629-51. Review.
Starting date: May 2003
Ending date: March 2005
Last updated: September 20, 2006