Overview

Zonisamide for Weight Reduction in Obese Adults

Status:
Completed

Trial end date:
2011-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Duke University

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Treatments:

Zonisamide

Criteria

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)

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