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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Weight-Gain Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Mifepristone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Thad Block, MD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

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St. John's Medical College

Bangalore, , India

Site Status

Countries

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India

References

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Beebe KL, Block T, Debattista C, Blasey C, Belanoff JK. The efficacy of mifepristone in the reduction and prevention of olanzapine-induced weight gain in rats. Behav Brain Res. 2006 Aug 10;171(2):225-9. doi: 10.1016/j.bbr.2006.03.039. Epub 2006 Jun 19.

Reference Type BACKGROUND

PMID: 16782211 (View on PubMed)

Other Identifiers

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C-1073-200

Identifier Type: -

Identifier Source: org_study_id