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

This study has been terminated.
(Interim Analysis result indicated the study will not show a significant benefit of the study medication on the primary endpoint.)
Sponsor:
Information provided by:
OBEcure Ltd.
ClinicalTrials.gov Identifier:
NCT00428168
First received: January 25, 2007
Last updated: October 29, 2008
Last verified: October 2008
  Purpose

This is a randomized, double-blind, placebo-controlled, multicenter, multinational study. Approximately 78 subjects (39 per treatment group) will be randomized into this 16 week study.

A screening visit will be used to determine subject suitability for inclusion in the trial.

Within 7 days of the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following 2 treatment groups:

  • Olanzapine OD plus betahistine 24 mg BID (48 mg/day total),
  • Olanzapine OD plus matching placebo BID.

Double-blind treatment will continue for 16 weeks. During this period, olanzapine dosage will be determined according to the discretion of the treating physician. In addition, 5 study visits (at 2, 4, 8, 12, and 16 weeks) will take place. Study medication (betahistine or matching placebo) will be administered BID (in the morning and together with olanzapine in the evening).

The primary statistical hypothesis to be tested is that the mean change from Baseline to Week 16 will be different between the treatment and placebo groups


Condition Intervention Phase
Weight Gain
Drug: Betahistine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight Gain Due to Olanzapine Treatment

Resource links provided by NLM:


Further study details as provided by OBEcure Ltd.:

Primary Outcome Measures:
  • The change in body weight from Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of weight change [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change in waist circumference from Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Changes from Baseline to Week 16 in measurements of obesity associated cardiovascular risk factors: sitting systolic and diastolic blood pressure, plasma lipid profile (LDL, non-HDL-C, TG, TC, and HDL-C), HbA1c, and FPG [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
  • Change in the pharmacokinetic properties of olanzapine due to betahistine co-administration [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change in psychiatric condition since randomization [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: March 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Betahistine
    Betahistine 24mg BID
  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject (or legal guardian) is capable and willing to provide signed written informed consent;
  • Male or female subjects 16 to 45 years of age;
  • Body mass index in the range of 18.5 to 35 kg/m2;
  • Diagnosed as having schizophrenia, schizoaffective disorder, schizophreniform disorder or a psychosis disorder that is not otherwise specified (NOS) according to the DSM-IV criteria;
  • Maximum of 6 weeks cumulative lifetime exposure to risperidone, OR maximum of 3 weeks cumulative lifetime exposure to any other antipsychotic medication;
  • Designated by the managing physician to be appropriate for treatment with olanzapine; and
  • If female: is non-lactating, has a negative blood serum pregnancy test result, and does not plan on becoming pregnant during the study, or is not of childbearing potential (hysterectomy or tubal ligation at least 6 months prior to randomization or post-menopausal for 1 year); if of childbearing potential (including peri-menopausal women who have had a menstrual period within one year), must practice and be willing to continue to practice appropriate birth control (such as implants, injectables, oral contraceptives, intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire study duration.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428168

Locations
Canada, Alberta
Capital Health, Edmonton Mental Health Clinic
Edmonton, Alberta, Canada, T5K 2J5
Canada, British Columbia
Dr. Alexander McIntyre
Penticton, British Columbia, Canada, V2A 4M4
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 4Z3
Canada, Manitoba
Dr. Ivan Kowalchuk
Winnipeg, Manitoba, Canada, R3K 2E2
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 2E2
Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 5G2
Canada, Quebec
Douglas Hospital Research Centre
Verdun (Montreal), Quebec, Canada, H4H 1R3
Israel
Abarbanel Hospital
Bat Yam, Israel
Geha Psychiatric Hospital
Petach Tikva, Israel, 49100
Lev Hasharon
Tirat Hacarmel, Israel
Sponsors and Collaborators
OBEcure Ltd.
Investigators
Study Chair: Yaffa Beck OBEcure Ltd.
  More Information

No publications provided

Responsible Party: Yaffa Beck, Obecure Ltd.
ClinicalTrials.gov Identifier: NCT00428168     History of Changes
Other Study ID Numbers: BET202
Study First Received: January 25, 2007
Last Updated: October 29, 2008
Health Authority: Canada: Health Canada
Israel: Ministry of Health

Keywords provided by OBEcure Ltd.:
Betahistine
Weight Gain Control
Weight Gain due to Olanzapine Treatment
Obesity
Schizophrenic disorder

Additional relevant MeSH terms:
Body Weight
Weight Gain
Body Weight Changes
Signs and Symptoms
Betahistine
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Histamine Agents
Histamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 20, 2014