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

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ClinicalTrials.gov Identifier: NCT00455442
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : September 19, 2008
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Weight-Gain Prevention Drug: Mifepristone Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00455442     History of Changes
Other Study ID Numbers: C-1073-200
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes
Olanzapine
Mifepristone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital