Clinical trial NCT00709371 (phase 2, status: completed)
Conditions: obesity
ICD codes: E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: zonisamide sr placebo/ bupropion sr placebo, zonisamide sr placebo/ bupropion sr 360 mg/day, zonisamide sr 120 mg/day/ bupropion sr placebo, zonisamide sr 360 mg/day/ bupropion sr placebo, zonisamide sr 120 mg/day/ bupropion sr 360 mg/day, zonisamide sr 360 mg/day/ bupropion sr 360 mg/day
SMILES: NS(=O)(=O)CC1=NOC2=CC=CC=C12, NS(=O)(=O)CC1=NOC2=CC=CC=C12, NS(=O)(=O)CC1=NOC2=CC=CC=C12, NS(=O)(=O)CC1=NOC2=CC=CC=C12, NS(=O)(=O)CC1=NOC2=CC=CC=C12, NS(=O)(=O)CC1=NOC2=CC=CC=C12
Eligibility criteria:

        Inclusion Criteria:

          -  Female or male subjects, 18 to 65 years of age

          -  Have body mass index (BMI) ≥ 30 kg/m2 and ≤ 45 kg/m2 for subjects with uncomplicated
             obesity, and BMI of ≥ 27 kg/m2 and ≤ 45 kg/m2 for subjects with obesity and
             dyslipidemia and/or controlled hypertension

          -  Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to
             screening

          -  Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications
             are allowed with the exception of adrenergic blockers and clonidine. Medical regimen
             must be stable for at least 6 weeks prior to randomization

          -  Triglycerides <400 mg/dL. Medications for treatment of dyslipidemia are allowed with
             the exception of cholestyramine and cholestypol as long as medical regimen has been
             stable for at least 6 weeks prior to randomization

          -  No clinically significant laboratory abnormalities

          -  Negative urine drug screen

          -  Negative serum pregnancy test in women of child-bearing potential

          -  Women of child-bearing potential must be non-lactating, and agree to use acceptable
             contraception throughout the study period and for 30 days after discontinuation of
             study drug

          -  Able to comply with all required study procedures and schedule

          -  Able to speak and read English

          -  Willing and able to give written informed consent

        Exclusion Criteria:

          -  Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism,
             Cushing's syndrome, polycystic ovary syndrome)

          -  Serious medical condition

          -  History of malignancy within the previous 5 years, with exception of non-melanoma skin
             cancer or surgically cured cervical cancer.

          -  History of suicide attempt or serious psychiatric illness

          -  History of Major Depressive Disorder within the past 2 years

          -  In need of medications for the treatment of a psychiatric disorder (with the exception
             of short-term insomnia) within the previous 6 months prior to randomization

          -  Type I or Type II diabetes

          -  History of alcohol or drug abuse or dependence as determined by the Investigator
             within 1 year prior to randomization

          -  History of surgical or device (e.g. gastric banding) intervention for obesity

          -  History of seizures or predisposition to seizures

          -  History of hypersensitivity to sulfonamides ("sulfa"), bupropion, or zonisamide

          -  History of treatment with bupropion SR (Wellbutrin, Zyban) or zonisamide (Zonegran)
             within previous 12 months

          -  History of nephrolithiasis (renal calculi)

          -  Loss or gain of more than 4.0 kg within 3 months prior to randomization

          -  Women of child bearing potential not adhering to a medically acceptable form of
             contraception

          -  Pregnant or breast-feeding women or planning to become pregnant during the study
             period or within 30 days of discontinuing study drug