Study to Examine the Effect of Betahistine on Body Weight Gain Due to Olanzapine Treatment

Exclusion Criteria

• •Has obesity of known endocrine origin (e.g., Cushing's disease, Addison's disease, hypothalamic tumor);
• •Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics (e.g., polydactyly) suggestive of genetic obesity (e.g., ob/ob genotype) or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome);
• •Previous surgical procedures for weight loss;
• •Has had liposuction within 1 year before screening or is planning to have liposuction during the study;
• •Has a clinically significant history or presence of any of the following conditions:
• •Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
• •Type 1 diabetes mellitus;
• •Type 2 diabetes mellitus with treatment other than metformin monotherapy and/or diet with HbA1c \>8%;
• •Severe type 2 diabetes with history of ketoacidosis or diabetic ulcers, or presence of retinopathy, neuropathy, or nephropathy;
• •Renal insufficiency defined as a serum creatinine \>=1.5 mg/dL (133 µmol/L) at screening;
• •Malignant disease, other than basal cell carcinoma, within 5 years of screening;
• •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2 x ULN;
• •Thyroid-stimulating hormone (TSH) outside of the normal range;
• •Plans on having any surgery (elective or otherwise) during the course of the study;
• •Has uncontrolled hypertension (sitting blood pressure \>160/95 mmHg at screening or randomization), uncontrolled hyperlipidemia (triglycerides \[TG\] \>=400 mg/dL or low-density lipoprotein cholesterol \[LDL\] \>160 mg/dL), or uncontrolled diabetes (HbA1c \>8%);
• •Diagnosis of asthma;
• •History of peptic ulcers;
• •History of HIV;
• •Has a physical examination or electrocardiogram (ECG) with significant abnormalities, as judged by the investigator;
• •Chronic antihistamine use or use of antihistamines within 14 days of randomization;
• •History of pheochromocytoma
• •Requires treatment with any of the following medications but has not been on a stable treatment regimen for a minimum of 90 days prior to screening:
• •Hormone replacement therapy;
• •Oral contraceptives;
• •Antihypertensive agents;
• •Metformin;
• •Lipid-lowering agents; or
• •Thyroid replacement therapy;
• •Has been treated over the past 60 days, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications;
• •All prescription or over-the-counter agents taken for the purpose of weight reduction, including (but not limited to) the following anti obesity agents:
• •Prescription drugs such as orlistat (Xenical), sibutramine (Meridia), and phentermine (Adipex-P, Celltech, Pro-Fast SA, Pro-Fast SR, Fastin, Oby trim, Zantryl, Teramine, Phentride, Phentercot, Obephen, Oby-cap); or
• •Over-the-counter antiobesity agents (e.g., herbal supplements or other alternative remedies such as Cortislim, Dexatrim, Acutrim);
• •Systemic steroids administered by oral, intravenous, or intramuscular route;
• •Drugs that directly affect gastrointestinal motility (e.g., Reglan® and Propulsid®, and chronic \[taken for more than 10 days within a 6-month period\] macrolide antibiotics such as erythromycin and newer derivatives);
• •Anti-depressants or benzodiazepines unless one of the following permitted drugs: escitalopram (Cipralex®), citalopram (Celexa®), clonazepam (Clonapam®), alprazolam (Xanax®), chlordiazepoxide (Librium®), diazepam (Valium®) and lorazepam (Ativan®);
• •Calcitonin (e.g., Miacalcin®);
• •Insulin;
• •Exenatide (Byeta®);
• •Sulfonylureas (e.g., Diamicron®, Amaryl®, Glucotrol®, Micronase®); or
• •Meglitinides (e.g., Starlix®, Prandin®);
• •Receipt of any investigational treatment (drug or device) within 90 days prior to screening; or
• •Is an immediate family member of personnel directly affiliated with the study at the investigative sites, or is personally directly affiliated with the study at the investigative sites.