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
Results First Received: November 4, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Healthy
Interventions: Drug: risperidone
Drug: risperidone matched placebo
Drug: risperidone-matched placebo
Drug: Mifepristone-matched placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Mifepristone Plus Risperidone mifepristone plus risperidone daily
Risperidone Plus Mifepristone-matched Placebo risperidone plus mifepristone-matched placebo daily
Risperidone-matched Placebo Plus Mifepristone risperidone-matched placebo plus mifepristone daily

Participant Flow:   Overall Study
    Mifepristone Plus Risperidone     Risperidone Plus Mifepristone-matched Placebo     Risperidone-matched Placebo Plus Mifepristone  
STARTED     30     30     16  
COMPLETED     14     20     14  
NOT COMPLETED     16     10     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Mifepristone Plus Risperidone mifepristone plus risperidone daily
Risperidone Plus Mifepristone-matched Placebo risperidone plus mifepristone-matched placebo daily
Risperidone-matched Placebo Plus Mifepristone risperidone-matched placebo plus mifepristone daily
Total Total of all reporting groups

Baseline Measures
    Mifepristone Plus Risperidone     Risperidone Plus Mifepristone-matched Placebo     Risperidone-matched Placebo Plus Mifepristone     Total  
Number of Participants  
[units: participants]
  30     30     16     76  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     30     30     16     76  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  24.6  ± 3.9     25.6  ± 3.6     24.9  ± 4.6     25  ± 3.9  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     30     30     16     76  
Region of Enrollment  
[units: participants]
       
India     30     30     16     76  



  Outcome Measures

1.  Primary:   Change in Weight (kg) From Baseline to Day 28.   [ Time Frame: baseline and 28 days ]

2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers.   [ Time Frame: 28 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Robert Roe, MD
Organization: Corcept_Therapeutics
phone: 650-688-8812
e-mail: rroe@corcept.com


Publications:

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00698022     History of Changes
Other Study ID Numbers: C-1073-205
Study First Received: June 12, 2008
Results First Received: November 4, 2010
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India