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Weight GainPhase 2NCT00428168

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

A Phase 2 study testing Betahistine in people with Weight Gain, run by OBEcure Ltd. at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 45 years
Conditions the study is for
Weight Gain
What is being tested?
Betahistine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
10 sitesin 2 countries
Study dates
Mar 2007to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Canada7 sites

  • Capital Health, Edmonton Mental Health Clinic

    Edmonton, Alberta, T5K 2J5

  • Capital District Health Authority

    Halifax, Nova Scotia, B3H 2E2

  • Queen's University

    Kingston, Ontario, K7L 5G2

  • Dr. Alexander McIntyre

    Penticton, British Columbia, V2A 4M4

  • Douglas Hospital Research Centre

    Verdun (Montreal), Quebec, H4H 1R3

  • Vancouver Island Health Authority

    Victoria, British Columbia, V8R 4Z3

  • Dr. Ivan Kowalchuk

    Winnipeg, Manitoba, R3K 2E2

Other trials in Canada

Israel3 sites

  • Abarbanel Hospital

    Bat Yam

  • Geha Psychiatric Hospital

    Petah Tikva, 49100

  • Lev Hasharon

    Tirat Hacarmel

Other trials in Israel

About this study

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

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.

Read more

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
Being tested
Betahistine
Keywords
Betahistine, Weight Gain Control, Weight Gain due to Olanzapine Treatment, Obesity, Schizophrenic disorder
Medical subject headings
Weight Gain, Obesity, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BetahistineDrug

    Betahistine 24mg BID

Study groups in NCT00428168
Study groupRoleWhat they receive
Betahistine 24 mgExperimentalNot described
Receives: Drug: Betahistine
PlaceboPlacebo comparatorNot described
Receives: Drug: Betahistine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in body weight from Baseline to Week 16

    Measured: Week 16

Secondary outcomes (5)

  1. Rate of weight change

    Measured: Week 16

  2. Change in waist circumference from Baseline to Week 16

    Measured: Week 16

  3. 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

    Measured: Week 16

  4. Change in the pharmacokinetic properties of olanzapine due to betahistine co-administration

    Measured: Week 16

  5. Change in psychiatric condition since randomization

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionAug 2008
  4. Study completionDec 2008

Why it stopped: Interim Analysis result indicated the study will not show a significant benefit of the study medication on the primary endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00428168
Sponsor's protocol ID
BET202
Status last verified
Oct 2008
First submitted
25 Jan 2007
Last updated
15 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Betahistine in people with Weight Gain, run by OBEcure Ltd. at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Interim Analysis result indicated the study will not show a significant benefit of the study medication on the primary endpoint.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in body weight from Baseline to Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00428168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.

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