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

NCT00203450 | Completed Phase 4

• 1 other identifier: TREAC Zonegran for Weight Loss
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; zonisamide; zonegran; psychotropic weight gain; psychotropic

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Study Arms (2)

Zonegran

EXPERIMENTAL

Zonegran

Drug: Zonegran

Placebo

PLACEBO COMPARATOR

Placebo pill

Drug: Placebo

Interventions

Zonegran DRUG

zonisamide

Also known as: zonisamide

Zonegran

Placebo DRUG

Placebo pill

Also known as: placebo pill

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• All conventional neuroleptics. All atypical neuroleptics except aripiprazole or ziprasidone. All forms of valproate. All forms of lithium. All forms of carbamazepine.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tuscaloosa Research & Education Advancement Corporation: lead
• Eisai Inc.: collaborator

Study Sites (1)

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (1)

• 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.

  PMID: 15270593 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lori L Davis, MD

  Tuscaloosa Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ACOS R&D

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: May 1, 2003
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2006
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

US (1)