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Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University
ClinicalTrials.gov Identifier:
NCT00285818
First received: January 31, 2006
Last updated: December 23, 2016
Last verified: December 2016
Results First Received: October 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Mifepristone
Drug: Placebo Oral Capsule

  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
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Reporting Groups
  Description
Mifepristone

Patients receive mifepristone one day before and for 5 additional days after starting ECT

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Placebo

Patients receive a placebo capsule one day before and for 5 additional days after starting ECT

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.


Participant Flow:   Overall Study
    Mifepristone   Placebo
STARTED   6   5 
COMPLETED   2   3 
NOT COMPLETED   4   2 
Withdrawal by Subject                3                2 
Lost to Follow-up                1                0 



  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

Patients receive mifepristone one day before and for 5 additional days after starting ECT

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Placebo

Patients receive a placebo pill one day before and for 5 additional days after starting ECT

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Total Total of all reporting groups

Baseline Measures
   Mifepristone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   5   11 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6 100.0%      5 100.0%      11 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.2  (5.2)   48.5  (6.2)   48.3  (5.3) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  83.3%      3  60.0%      8  72.7% 
Male      1  16.7%      2  40.0%      3  27.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  16.7%      0   0.0%      1   9.1% 
White      5  83.3%      5 100.0%      10  90.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   6   5   11 


  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale Score   [ Time Frame: Screening to Final Visit ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Hugh Brent Solvason
Organization: Stanford University
phone: 650 776 4793
e-mail: solvason@stanford.edu



Responsible Party: Hugh Brent Solvason, Stanford University
ClinicalTrials.gov Identifier: NCT00285818     History of Changes
Other Study ID Numbers: 2HSE450
Oberndorf Family Fund ( Other Identifier: Stanford University )
Study First Received: January 31, 2006
Results First Received: October 20, 2016
Last Updated: December 23, 2016