CONTEXT: Zonisamide is a marketed antiepileptic drug that has serotonergic and dopaminergic activity in addition to blockade of sodium and calcium channels. In an intent-to-treat analysis using the available data for all randomized participants with the last observation carried forward, the zonisamide group lost more body weight than the placebo group (mean [SE], 5.9 [0.8] kg [6.0% loss] vs 0.9 [0.4] kg [1.0% loss]; t = 5.5; P<.001) during the 16-week period. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. OBJECTIVE: To evaluate the efficacy of zonisamide for weight loss in obese adults. The higher the score, the more severe the anxiety or depression.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Weight loss was an adverse effect associated with zonisamide treatment in epilepsy clinical trials. Diabetes Obes Metab. Zonisamide for Weight Reduction in Obese Adults Gadde, Kishore M. Duke University, Durham, NC, United States. RESULTS: Of the 60 randomized patients, 51 completed the 16-week acute phase.
Seventeen (57%) of 30 in the zonisamide group and 3 (10%) of 30 in the placebo group lost at least 5% of body weight (P<.001) by week 16. The measures were modeled with logistic regressions that included the three-level group proxy and a baseline weight covariate.This outcomes measure followed the same principles at measurement of proportions of patients with 5% weight loss described elsewhere.Analyses was based on intent-to-treat ANCOVA. 2014 Aug;16(8):766-8. doi: 10.1111/dom.12275. CONCLUSION: In this short-term, preliminary trial, zonisamide and hypocaloric diet resulted in more weight loss than placebo and hypocaloric diet in the treatment of obesity. COVID-19 is an emerging, rapidly evolving situation. Of the 37 participants who entered the extension phase, 36 completed week 32. Epub 2014 Mar 10. MAIN OUTCOME MEASURE: Change in body weight. A randomized double‐blind placebo‐controlled trial in 60 obese adults was conducted to determine if zonisamide could be used as a weight loss drug. 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.The primary endpoint was weight loss at 1-year, Month-12 weight minus baseline weight, in kilograms.These were the proportions of patients losing 5% or more weight at 1-year relative to baseline. Weight loss was an adverse effect associated with zonisamide treatment in epilepsy clinical trials.
The primary outcome measure is change in body weight in kilograms. Zonisamide is an antiepileptic drug that demonstrated weight loss efficacy in obese adults (−5.9 vs −0.9 kg) in a 16-week trial with further weight loss in the additional 16-week extension phase. DESIGN AND SETTING: Sixteen-week randomized, double-blind, placebo-controlled trial with an optional single-blind extension of the same treatment for another 16 weeks, conducted at Duke University Medical Center from March 2001 to March 2002. All were also placed on a hypocaloric diet. 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)
PARTICIPANTS: Fifty-five (92%) women and 5 (8%) men (mean [SE] body mass index, 36.3 [0.5]; mean age, 37.0 (1.0) years). At the end of 16 weeks 57% in the zonisamide group compared to 10% in the placebo group lost weight …
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.