A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00698022
First received: June 12, 2008
Last updated: May 1, 2012
Last verified: May 2012

June 12, 2008
May 1, 2012
November 2008
February 2009   (final data collection date for primary outcome measure)
Change in Weight (kg) From Baseline to Day 28. [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
Change in weight (kg) was compared at Baseline and Day 28 for all subjects in all treatment arms.
The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00698022 on ClinicalTrials.gov Archive Site
  • The Secondary Study Objectives Are to Determine the Mean Percent Change in Baseline Body Weight; and the Proportion of Subjects That Gain Less Than 5% and Less Than 7% of Their Baseline Body Weight in the Treatment Groups. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The safety objective is to evaluate the safety and tolerability of mifepristone in combination with risperidone in healthy male volunteers. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
A 4-week, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.

This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Healthy
  • Drug: risperidone
    daily risperidone plus mifepristone for 28 days
    Other Name: Risperdal
  • Drug: risperidone matched placebo
    risperidone-matched placebo plus mifepristone daily for 28 days
    Other Names:
    • Risperdal
    • Corlux
  • Drug: risperidone-matched placebo
    daily risperidone-matched placebo plus mifepristone for 28 days
    Other Name: Risperdal
  • Drug: Mifepristone-matched placebo
    daily mifepristone-matched placebo for 28 days
    Other Names:
    • Corlux
    • Risperdal
  • Experimental: Risperidone plus mifepristone
    risperidone plus mifepristone daily for 28 days
    Intervention: Drug: risperidone
  • Placebo Comparator: risperidone plus mifepristone-matched placebo
    risperidone plus mifepristone-matched placebo daily for 28 days
    Intervention: Drug: Mifepristone-matched placebo
  • Placebo Comparator: risperidone matched-placebo plus mifepristone
    risperidone-matched placebo plus mifepristone daily for 28 days
    Interventions:
    • Drug: risperidone matched placebo
    • Drug: risperidone-matched placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI ≥ 18 and ≤ 23 kg/m2
  • Able to provide written informed consent
  • Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
  • AST, ALT, Tbili within normal limits at screening
  • Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study
  • Agree to use a barrier method of birth control for 28 days following the last dose of study medication
  • Have maintained a stable weight for at least 6 months prior to Screening

Exclusion Criteria:

  • 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 drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician
  • 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 risperidone
  • Any other clinically significant abnormality on screening laboratory tests
  • QTc Bazzett's ≥ 450 msec
  • History of or current 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
  • Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism
  • Any personal or family history of Neuroleptic Malignant Syndrome
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00698022
C-1073-205
No
Corcept Therapeutics
Corcept Therapeutics
Not Provided
Study Director: Coleman Gross, MD Corcept Therapeutics
Corcept Therapeutics
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP