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

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

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00455442

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

Additional Information:
Publications: Identifier: NCT00455442     History of Changes
Other Study ID Numbers: C-1073-200
Study First Received: March 30, 2007
Last Updated: September 18, 2008

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors processed this record on May 25, 2017