A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain
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
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 30, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedSeptember 19, 2008
September 1, 2008
March 30, 2007
September 18, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.
Secondary Outcomes (1)
To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corcept Therapeuticslead
- Eli Lilly and Companycollaborator
Study Sites (1)
St. John's Medical College
Bangalore, India
Related Publications (1)
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.
PMID: 16782211BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thad Block, MD
Corcept Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 30, 2007
First Posted
April 3, 2007
Study Start
March 1, 2007
Study Completion
July 1, 2007
Last Updated
September 19, 2008
Record last verified: 2008-09