We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Zonisamide for Weight Reduction in Obese Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275834
First Posted: January 12, 2006
Last Update Posted: January 12, 2017
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
January 10, 2006
January 12, 2006
December 10, 2012
January 16, 2013
January 12, 2017
January 2006
September 2011   (Final data collection date for primary outcome measure)
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.
Change in Body Weight
Complete list of historical versions of study NCT00275834 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • Inflammatory Markers (CRP) [ Time Frame: 1 year ]
    C reactive Protein (CRP)
  • Change in Lipids [ Time Frame: baseline, 1 year ]
  • 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.
  • Change in Blood Pressure [ Time Frame: Baseline, 1 year ]
  • Proportions of patients with 5% and 10% weight loss
  • Waist Circumference
  • Glycaemic indices
  • Inflammatory Markers
  • Lipids
  • Quality of Life
  • Psychological Measures
  • Blood Pressure
Not Provided
Not Provided
 
Zonisamide for Weight Reduction in Obese Adults
Zonisamide for Weight Reduction in Obese Adults
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
Drug: Zonisamide
zonisamide 400 mg, 200 mg, or placebo
  • Experimental: A
    Zonisamide 400 mg
    Intervention: Drug: Zonisamide
  • Experimental: B
    Zonisamide 200 mg
    Intervention: Drug: Zonisamide
  • Placebo Comparator: C
    matching placebo
    Intervention: Drug: Zonisamide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
September 2011
September 2011   (Final data collection date for primary outcome measure)

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)

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00275834
Pro00005514
R01DK067352 ( U.S. NIH Grant/Contract )
1R01DK067352 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Duke University
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Kishore M Gadde, MD Duke University
Duke University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP