A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

September 18, 2008 updated by: Corcept Therapeutics

A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers

This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India
        • St. John's Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers between 18 and 40 years of age
  • BMI between ≥ 18 and ≤ 25
  • Able to provide written informed consent
  • Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits

Exclusion Criteria:

  • History of Cushing's syndrome or Addison's disease
  • Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
  • Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
  • Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
  • Have a history of an allergic reaction to either mifepristone or olanzapine
  • Any clinically significant abnormality on screening laboratory tests
  • QTc Bazzett's ≥ 450 msec
  • Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
  • Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
  • History of recent (within 6 months of screening) significant weight fluctuation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.

Secondary Outcome Measures

Outcome Measure
To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Thad Block, MD, Corcept Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

March 30, 2007

First Submitted That Met QC Criteria

March 30, 2007

First Posted (ESTIMATE)

April 3, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-1073-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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