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Trial record 1 of 3 for:    corcept pittsburgh
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A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features

This study has been terminated.
(DRC recommended stopping study as it had missed its primary endpoint)
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00637494
First received: March 11, 2008
Last updated: May 4, 2017
Last verified: May 2017
Results First Received: December 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Psychotic Depression
Severe Major Depression With Psychotic Features
Psychosis
Interventions: Drug: mifepristone
Drug: 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 1200 mg/Day Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
Matching Placebo Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56

Participant Flow:   Overall Study
    Mifepristone 1200 mg/Day   Matching Placebo
STARTED   141   151 
COMPLETED   109   108 
NOT COMPLETED   32   43 



  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.
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Reporting Groups
  Description
Mifepristone Followed by an Antidepressant Mifepristone 1200 mg/day on Days 1-7 and a single-study approved antidepressant on Days 8-56
Matching Placebo Matching placebo on Days 1-7 and a single-study approved antidepressant on Days 8-56
Total Total of all reporting groups

Baseline Measures
   Mifepristone Followed by an Antidepressant   Matching Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 141   151   292 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      141 100.0%      147  97.4%      288  98.6% 
>=65 years      0   0.0%      4   2.6%      4   1.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (9.0)   47.0  (9.5)   46.2  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      76  53.9%      85  56.3%      161  55.1% 
Male      65  46.1%      66  43.7%      131  44.9% 
Region of Enrollment 
[Units: Participants]
     
United States   141   151   292 


  Outcome Measures
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1.  Primary:   Proportion of Mifepristone vs. Placebo Treated Patients With at Least a 50% Reduction From Baseline in Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PSS) at Days 7 and 56   [ Time Frame: 56 days ]

2.  Secondary:   Proportion of Mifepristone Treated Patients With Plasma Drug Concentrations Equal to or Above 1637 ng/mL vs. Placebo Treated Patients Who Achieve a ≤ 50% Reduction in BPRS-PSS at Days 7 and 56   [ Time Frame: 56 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 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.


Results Point of Contact:  
Name/Title: Thaddeus S. Block, MD
Organization: Corcept Therapeutics
phone: (650) 688-8816
e-mail: tblock@corcept.com


Publications:

Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00637494     History of Changes
Other Study ID Numbers: C-1073-14
Study First Received: March 11, 2008
Results First Received: December 23, 2016
Last Updated: May 4, 2017