Weight-Gain Prevention Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Country | Name | City | State |
|---|---|---|---|
| India | St. John's Medical College | Bangalore |
| Lead Sponsor | Collaborator |
|---|---|
| Corcept Therapeutics | Eli Lilly and Company |
India,
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. Epub 2006 Jun 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers. | |||
| Secondary | To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers. |