Trial Outcomes & Findings for Mifepristone in Refractory Depression (NCT NCT00186056)

NCT ID: NCT00186056

Last Updated: 2017-04-05

Results Overview

Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed). Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline and Day 35 HAMD scores
• Results posted on: 2017-04-05

Participant Flow

Participant milestones

Measure	Mifepristone Patients received mifepristone for 6 days Mifepristone: Glucocorticoid antagonist	Placebo Patients received placebo for 6 days Mifepristone: Glucocorticoid antagonist
Overall Study STARTED	14	17
Overall Study COMPLETED	12	16
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mifepristone in Refractory Depression

Baseline characteristics by cohort

Measure	Mifepristone n=14 Participants Patients received mifepristone for 6 days Mifepristone: Glucocorticoid antagonist	Placebo n=17 Participants Patients received placebo for 6 days Mifepristone: Glucocorticoid antagonist	Total n=31 Participants Total of all reporting groups
Age, Continuous	50.92 years STANDARD_DEVIATION 9.4 • n=5 Participants	51.82 years STANDARD_DEVIATION 9.6 • n=7 Participants	51.43 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	14 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	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 35 HAMD scores

Hamilton Depression Rating Scale. Minimum score of 0 (no depressive symptoms) to maximum of 68 (very severely depressed).

Outcome Measure is reporting a Change from Baseline in HAMD scores, i.e., scores at Day 35 minus scores at Baseline.

Outcome measures

Measure	Mifepristone n=12 Participants Patients received mifepristone for 6 days Mifepristone: Glucocorticoid antagonist	Placebo n=16 Participants Patients received placebo for 6 days Mifepristone: Glucocorticoid antagonist
Hamilton Depression Rating Scale	18.75 units on a scale Standard Deviation 9.1	19.68 units on a scale Standard Deviation 5.5

Adverse Events

Mifepristone

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Brent Solvason

Stanford University

Phone: 650-723-8331

Email: solvason@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place