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

NCT00428168 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-10-15

No results posted yet for this study

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

Interventions

DRUG

Betahistine

Betahistine 24mg BID

Sponsors & Collaborators

  • OBEcure Ltd.

    lead INDUSTRY

Principal Investigators

  • Yaffa Beck · OBEcure Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-08-31
Completion
2008-12-31

Countries

  • Canada
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00428168 on ClinicalTrials.gov