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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00455442
First received: March 30, 2007
Last updated: September 18, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Weight-Gain Prevention
Drug: Mifepristone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.

Secondary Outcome Measures:
  • To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.

Enrollment: 57
Study Start Date: March 2007
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455442

Locations
India
St. John's Medical College
Bangalore, India
Sponsors and Collaborators
Corcept Therapeutics
Eli Lilly and Company
Investigators
Study Director: Thad Block, MD Corcept Therapeutics
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00455442     History of Changes
Other Study ID Numbers: C-1073-200
Study First Received: March 30, 2007
Last Updated: September 18, 2008
Health Authority: United States: Food and Drug Administration
India: Institutional Review Board

Additional relevant MeSH terms:
Body Weight
Weight Gain
Body Weight Changes
Signs and Symptoms
Mifepristone
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014