Zonisamide for Weight Reduction in Obese Adults

Not Applicable

Completed

Conditions: Obesity

Interventions: Drug: Zonisamide

Registration Number: NCT00275834

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Zonisamide	Zonisamide 200 mg
A	Zonisamide	Zonisamide 400 mg
C	Zonisamide	matching placebo

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	1 year	The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.

Secondary Outcome Measures

Name	Time	Method
Change in Blood Pressure	Baseline, 1 year
Proportions of Patients With 5% Weight Loss	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	1 year	This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.
Waist Circumference	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)	1 year	C reactive Protein (CRP)
Change in Lipids	baseline, 1 year
Quality of Life as Measured by HADS_D	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.