A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight Gain Due to Olanzapine Treatment

OBEcure Ltd.10 sites in 2 countries36 target enrollmentMarch 2007

ConditionsWeight Gain

InterventionsBetahistine

Overview

Phase: Phase 2
Intervention: Betahistine
Conditions: Weight Gain
Sponsor: OBEcure Ltd.
Enrollment: 36
Locations: 10
Primary Endpoint: The change in body weight from Baseline to Week 16
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

December 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OBEcure Ltd.

Responsible Party

Sponsor

Eligibility 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;

Arms & Interventions

Betahistine 24 mg

Intervention: Betahistine

Placebo

Intervention: Betahistine

Outcomes

Primary Outcomes

The change in body weight from Baseline to Week 16

Time Frame: Week 16

Secondary Outcomes

Rate of weight change(Week 16)
Change in waist circumference from Baseline to Week 16(Week 16)
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(Week 16)
Change in the pharmacokinetic properties of olanzapine due to betahistine co-administration(Week 16)
Change in psychiatric condition since randomization(Week 16)