Expired Study
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Tuscaloosa, Alabama 35404


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.


Study summary:

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.


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


Study is Available At:


Original ID:

TREAC Zonegran for Weight


NCT ID:

NCT00203450


Secondary ID:

TREAC Zonegran for Weight


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Tuscaloosa Research & Education Advancement Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:


Overall Contact Information

Official Name:Lori L Davis, MD
Principal Investigator
Tuscaloosa VA Medical Center

Study Dates

Start Date:May 2003
Completion Date:March 2005
Verification Date:September 2006
Last Changed Date:September 20, 2006
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Primary 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 wi
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:zonisamide

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Tuscaloosa Research & Education Advancement Corporation
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Eisai Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Appolinario JC, Bueno JR, Coutinho W. Psychotropic drugs in the treatment of obesity: what promise? CNS Drugs. 2004;18(10):629-51. Review.
PMID:15270593

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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