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

Phase 2

Completed

• Conditions: Weight-Gain Prevention

• Registration Number: NCT00455442
• Lead Sponsor: Corcept Therapeutics

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-30
• Study First Submitted QC: 2007-03-30
• Study First Posted: 2007-04-03
• Study Completion: 2007-07
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-18
• Last Update Posted: 2008-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.

Secondary Outcome Measures

Name	Time	Method
To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.

Trial Locations

Locations (1)

St. John's Medical College; 🇮🇳 Bangalore, India