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

NCT00428168 | Terminated Phase 2

• 1 other identifier: BET202
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 10

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

Conditions

Weight Gain

Keywords

Betahistine; Weight Gain Control; Weight Gain due to Olanzapine Treatment; Obesity; Schizophrenic disorder

Outcome Measures

Primary Outcomes (1)

• The change in body weight from Baseline to Week 16

  Week 16

Secondary Outcomes (5)

• 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

Study Arms (2)

Betahistine 24 mg

EXPERIMENTAL

Drug: Betahistine

Placebo

PLACEBO COMPARATOR

Drug: Betahistine

Interventions

Betahistine DRUG

Betahistine 24mg BID

Betahistine 24 mg; Placebo

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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%);

Sponsors & Collaborators

• OBEcure Ltd.: lead

Study Sites (10)

Capital Health, Edmonton Mental Health Clinic

Edmonton, Alberta, T5K 2J5, Canada

Location

Dr. Alexander McIntyre

Penticton, British Columbia, V2A 4M4, Canada

Location

Vancouver Island Health Authority

Victoria, British Columbia, V8R 4Z3, Canada

Location

Dr. Ivan Kowalchuk

Winnipeg, Manitoba, R3K 2E2, Canada

Location

Capital District Health Authority

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Queen's University

Kingston, Ontario, K7L 5G2, Canada

Location

Douglas Hospital Research Centre

Verdun (Montreal), Quebec, H4H 1R3, Canada

Location

Abarbanel Hospital

Bat Yam, Israel

Location

Geha Psychiatric Hospital

Petah Tikva, 49100, Israel

Location

Lev Hasharon

Tirat Hacarmel, Israel

Location

MeSH Terms

Conditions

Weight Gain; Obesity; Schizophrenia

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yaffa Beck

  OBEcure Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 15, 2015

Record last verified: 2008-10

Locations

IL (3); CA (7)