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

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ClinicalTrials.gov Identifier: NCT00203450
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Zonegran Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Study Start Date : May 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Zonegran
Zonegran
 Drug: Zonegran
zonisamide
Other Name: zonisamide
Placebo Comparator: Placebo
Placebo pill
 Drug: Placebo
Placebo pill
Other Name: placebo pill


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. NThe weight loss in patients treated with Zonisamide will be significantly greater than those treated with placebo.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203450


Locations
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United States, Alabama
Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Eisai Inc.
Investigators
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Principal Investigator: Lori L Davis, MD Tuscaloosa Veterans Affairs Medical Center
More Information
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Publications:

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Responsible Party: Lori Davis, MD, ACOS R&D, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00203450    
Other Study ID Numbers: TREAC Zonegran for Weight Loss
TREAC Zonegran for Weight Loss
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation:
obesity
zonisamide
zonegran
psychotropic weight gain
psychotropic
Additional relevant MeSH terms:
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Weight Gain
Body Weight
Body Weight Changes
Zonisamide
Anticonvulsants
 Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs