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

August 30, 2012 updated by: Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo pill
Drug: Placebo
Placebo pill
Other Names:
  • placebo pill
Experimental: Zonegran
Drug: Zonegran
zonisamide
Other Names:
  • zonisamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
NThe weight loss in patients treated with Zonisamide will be significantly greater than those treated with placebo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Collaborators

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREAC Zonegran for Weight Loss

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe