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

Sponsors and Collaborators:	Tuscaloosa Research & Education Advancement Corporation Eisai Inc.
Information provided by:	Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:	NCT00203450

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: zonisamide	Phase IV

MedlinePlus related topics: Obesity

Drug Information available for: Zonisamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial

Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	May 2003
Estimated Study Completion Date:	March 2005

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, 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 psychiatric condition.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203450

Locations

United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404

Sponsors and Collaborators

Tuscaloosa Research & Education Advancement Corporation

Eisai Inc.

Investigators

Principal Investigator:

Lori L Davis, MD

Tuscaloosa VA Medical Center

More Information

Publications:

Appolinario JC, Bueno JR, Coutinho W. Psychotropic drugs in the treatment of obesity: what promise? CNS Drugs. 2004;18(10):629-51. Review.

Study ID Numbers:	TREAC Zonegran for Weight Loss, TREAC Zonegran for Weight Loss
Study First Received:	September 12, 2005
Last Updated:	September 20, 2006
ClinicalTrials.gov Identifier:	NCT00203450
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:

obesity
zonisamide
zonegran
psychotropic weight gain
psychotropic

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Zonisamide
Body Weight Changes

Nutrition Disorders
Overweight
Overnutrition
Weight Gain

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Central Nervous System Agents
Protective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009