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

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

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 20, 2005
• Last Update Posted Date: September 3, 2012
• Study Start Date: May 2003
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 12, 2005): 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
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 30, 2012): NThe weight loss in patients treated with Zonisamide will be significantly greater than those treated with placebo.
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• 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
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• Drug: Zonegran
  zonisamide
  Other Name: zonisamide
• Drug: Placebo
  Placebo pill
  Other Name: placebo pill

Study Arms

• Experimental: Zonegran
  Zonegran
  Intervention: Drug: Zonegran
• Placebo Comparator: Placebo
  Placebo pill
  Intervention: Drug: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 30, 2012): 20
• Original Enrollment (submitted: September 12, 2005): 60
• Actual Study Completion Date: March 2006
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00203450
• Other Study ID Numbers: TREAC Zonegran for Weight Loss; TREAC Zonegran for Weight Loss
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
• Original Responsible Party: Not Provided
• Current Study Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Original Study Sponsor: Same as current
• Collaborators: Eisai Inc.

Investigators

• Principal Investigator: Lori L Davis, MD; Tuscaloosa Veterans Affairs Medical Center

• PRS Account: Tuscaloosa Research & Education Advancement Corporation
• Verification Date: August 2012