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

NCT ID: NCT00203450

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2006-03-31

Brief 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.

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.

Conditions

Obesity

Keywords

obesity; zonisamide; zonegran; psychotropic weight gain; psychotropic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zonegran

Zonegran

Group Type: EXPERIMENTAL

Zonegran

Intervention Type: DRUG

zonisamide

Placebo

Placebo pill

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pill

Interventions

Zonegran

zonisamide

Intervention Type: DRUG

Placebo

Placebo pill

Intervention Type: DRUG

Other Intervention Names

zonisamide; placebo pill

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: collaborator

Tuscaloosa Research & Education Advancement Corporation

OTHER

Sponsor Role: lead

Responsible Party

Lori Davis, MD

ACOS R&D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lori L Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Tuscaloosa Veterans Affairs Medical Center

Locations

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, United States

Countries

United States

References

Appolinario JC, Bueno JR, Coutinho W. Psychotropic drugs in the treatment of obesity: what promise? CNS Drugs. 2004;18(10):629-51. doi: 10.2165/00023210-200418100-00002.

Reference Type: BACKGROUND

PMID: 15270593 (View on PubMed)

Other Identifiers

TREAC Zonegran for Weight Loss

Identifier Type: -

Identifier Source: secondary_id

TREAC Zonegran for Weight Loss

Identifier Type: -

Identifier Source: org_study_id