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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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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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 ]

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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

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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
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Results Point of Contact:

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

Publications:

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.

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

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