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N/A Completed N=225 Randomized Quadruple-blind Treatment

Zonisamide for Weight Reduction in Obese Adults

Source: ClinicalTrials.gov NCT00275834 ↗
Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Change in Body Weight — -4.0; -4.4; -7.3 kg

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Body Weight
-4.0; -4.4; -7.3
SECONDARY
Proportions of Patients With 5% Weight Loss
23; 26; 41
SECONDARY
Proportions of Patients With 10% Weight Loss
6; 17; 24
SECONDARY
Waist Circumference
-4.8; -6.1; -8.5
SECONDARY
Inflammatory Markers (CRP)
0.523; 0.536; 0.443
SECONDARY
Change in Lipids
-1.9; 4.1; -0.1; -2.0; 1.7; -0.3
SECONDARY
Quality of Life as Measured by HADS_D
2.12; 2.76; 1.95
SECONDARY
Change in Blood Pressure
-0.6; -4.4; -1.9; -1.5; -3.6; -3.9

Eligibility 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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View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00275834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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