Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Tuscaloosa Research & Education Advancement Corporation Eisai Inc. |
---|---|
Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00203450 |
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 | Intervention | Phase |
---|---|---|
Obesity |
Drug: zonisamide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial |
Estimated Enrollment: | 60 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | March 2005 |
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.
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
United States, Alabama | |
Tuscaloosa Research & Education Advancement Corporation | |
Tuscaloosa, Alabama, United States, 35404 |
Principal Investigator: | Lori L Davis, MD | Tuscaloosa VA Medical Center |
Study ID Numbers: | TREAC Zonegran for Weight Loss, TREAC Zonegran for Weight Loss |
Study First Received: | September 12, 2005 |
Last Updated: | September 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00203450 History of Changes |
Health Authority: | United States: Food and Drug Administration |
obesity zonisamide zonegran psychotropic weight gain psychotropic |
Body Weight Signs and Symptoms Obesity Antioxidants Zonisamide Body Weight Changes |
Nutrition Disorders Overweight Overnutrition Weight Gain Anticonvulsants |
Obesity Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zonisamide Overweight Weight Gain Protective Agents Pharmacologic Actions |
Body Weight Signs and Symptoms Therapeutic Uses Body Weight Changes Nutrition Disorders Overnutrition Central Nervous System Agents Anticonvulsants |