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Trial record 32 of 1065 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

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

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ClinicalTrials.gov Identifier: NCT00285818
Recruitment Status : Completed
First Posted : February 2, 2006
Results First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hugh Brent Solvason, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: Mifepristone
Drug: Placebo Oral Capsule
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description

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

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

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

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Period Title: Overall Study
Started 6 5
Completed 2 3
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             3             2
Lost to Follow-up             1             0
Arm/Group Title Mifepristone Placebo Total
Hide Arm/Group Description

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

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

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

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
48.2  (5.2) 48.5  (6.2) 48.3  (5.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
5
  83.3%
3
  60.0%
8
  72.7%
Male
1
  16.7%
2
  40.0%
3
  27.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6 5 11
1.Primary Outcome
Title Hamilton Depression Rating Scale Score
Time Frame Screening to Final Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description:

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

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Patients receive a placebo pill one day before and for 5 additional days after starting ECT
Overall Number of Participants Analyzed 2 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 28.5  (3.9) 23.0  (5.7)
Visit 4; 4 weeks 20.5  (4.9) 19.0  (7.5)
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mifepristone Placebo
Hide Arm/Group Description

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

Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.

Patients receive a placebo pill one day before and for 5 additional days after starting ECT
All-Cause Mortality
Mifepristone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mifepristone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mifepristone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/5 (0.00%)    
Musculoskeletal and connective tissue disorders     
headache * [1]  1/6 (16.67%)  1 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Headache was of mild severity, related to non-specific muscle tension in the temporal and occipital area.
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
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 )
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: October 20, 2016
Results First Posted: February 16, 2017
Last Update Posted: February 16, 2017