Working… Menu

Zonisamide for Weight Reduction in Obese Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00275834
Recruitment Status : Completed
First Posted : January 12, 2006
Results First Posted : January 16, 2013
Last Update Posted : January 12, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

Condition or disease Intervention/treatment Phase
Obesity Drug: Zonisamide Not Applicable

Detailed Description:
This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zonisamide for Weight Reduction in Obese Adults
Study Start Date : January 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

Arm Intervention/treatment
Experimental: A
Zonisamide 400 mg
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo

Experimental: B
Zonisamide 200 mg
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo

Placebo Comparator: C
matching placebo
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo

Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: 1 year ]
    The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.

Secondary Outcome Measures :
  1. Proportions of Patients With 5% Weight Loss [ Time Frame: 1 year ]
    These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.

  2. Proportions of Patients With 10% Weight Loss [ Time Frame: 1 year ]
    This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.

  3. Waist Circumference [ Time Frame: 1 year ]
    Analyses was based on intent-to-treat ANCOVA. Difference scores from baseline to endpoint (Month-12) for each measure were regressed on the three-level proxy denoting group while controlling for the baseline value of the same measure. Contrasts were subsequently estimated in models, which had a significant overall treatment effect.

  4. Inflammatory Markers (CRP) [ Time Frame: 1 year ]
    C reactive Protein (CRP)

  5. Change in Lipids [ Time Frame: baseline, 1 year ]
  6. Quality of Life as Measured by HADS_D [ Time Frame: 1 year ]
    Hospital Anxiety and Depression Scale - Depression (HADS-D) The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.

  7. Change in Blood Pressure [ Time Frame: Baseline, 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Age 18-65 years; BMI 30-50

Exclusion Criteria:

Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks)


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 identifier (NCT number): NCT00275834

Layout table for location information
United States, North Carolina
Duke University Medical Centre
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Layout table for investigator information
Principal Investigator: Kishore M Gadde, MD Duke University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University Identifier: NCT00275834     History of Changes
Other Study ID Numbers: Pro00005514
R01DK067352 ( U.S. NIH Grant/Contract )
1R01DK067352 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2006    Key Record Dates
Results First Posted: January 16, 2013
Last Update Posted: January 12, 2017
Last Verified: November 2016
Keywords provided by Duke University:
obesity treatment
weight loss
antiobesity drugs
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs