Trial Outcomes & Findings for Mifepristone Treatment for Patients With Non-psychotic Major Depressive Disorder Receiving Bilateral ECT (NCT NCT00285818)

Last Updated: 2017-02-16

Results Overview

The Hamilton Depression Scale measures the severity of depression. There are 17 items rated 0 to 4. A total score of 0 indicates that the patient does not endorse any symptoms of depression. The maximum score (the most severe depression) is 68. The outcome measure is the difference between Visit 1 and Visit 4 Hamilton Depression Rating Scale scores of the mifepristone and placebo groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Screening to Final Visit

Results posted on

2017-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	6	5
Overall Study COMPLETED	2	3
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	3	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mifepristone n=6 Participants Patients receive mifepristone one day before and for 5 additional days after starting ECT Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.	Placebo n=5 Participants Patients receive a placebo pill one day before and for 5 additional days after starting ECT Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 5.2 • n=5 Participants	48.5 years STANDARD_DEVIATION 6.2 • n=7 Participants	48.3 years STANDARD_DEVIATION 5.3 • n=5 Participants
Gender Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Screening to Final Visit

Outcome measures

Outcome measures
Measure	Mifepristone n=2 Participants Patients receive mifepristone one day before and for 5 additional days after starting ECT Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.	Placebo n=3 Participants Patients receive a placebo pill one day before and for 5 additional days after starting ECT
Hamilton Depression Rating Scale Score Baseline	28.5 units on a scale Standard Deviation 3.9	23.0 units on a scale Standard Deviation 5.7
Hamilton Depression Rating Scale Score Visit 4; 4 weeks	20.5 units on a scale Standard Deviation 4.9	19.0 units on a scale Standard Deviation 7.5

Adverse Events

Mifepristone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mifepristone n=6 participants at risk Patients receive mifepristone one day before and for 5 additional days after starting ECT Mifepristone: Mifepristone is a glucocorticoid receptor antagonist.	Placebo n=5 participants at risk Patients receive a placebo pill one day before and for 5 additional days after starting ECT
Musculoskeletal and connective tissue disorders headache	16.7% 1/6 • Number of events 1 • 6 weeks	0.00% 0/5 • 6 weeks

Additional Information

Dr. Hugh Brent Solvason

Stanford University

Phone: 650 776 4793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place