Trial Outcomes & Findings for Treatment of Psychotic Major Depression With Mifepristone (NCT NCT00867360)

NCT ID: NCT00867360

Last Updated: 2017-04-04

Results Overview

The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms. For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms. The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: baseline to day 9
• Results posted on: 2017-04-04

Participant Flow

Participant milestones

Measure	Mifepristone Receive 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo Receive placebo rather than mifepristone Placebo: Placebo medication
Overall Study STARTED	4	6
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Mifepristone Receive 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo Receive placebo rather than mifepristone Placebo: Placebo medication
Overall Study Withdrawal by Subject	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Treatment of Psychotic Major Depression With Mifepristone

Baseline characteristics by cohort

Measure	Mifepristone n=3 Participants Receive 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo n=5 Participants Receive placebo rather than mifepristone Placebo: Placebo medication	Total n=8 Participants Total of all reporting groups
Age, Continuous	39.67 years STANDARD_DEVIATION 13.1 • n=5 Participants	40.00 years STANDARD_DEVIATION 9.98 • n=7 Participants	39.88 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to day 9

The BRPS is a rating scale of various psychiatric symptoms. Each item is rated on a scale of 1 to 7, with 1 being not present. The PSS is the sum of 4 items from the BPRS, which indicates the level of positive psychotic symptoms.. Thus, the range for the PSS is 4 to 28, with higher scores indicating greater levels of positive psychotic symptoms.

For ease of interpretation, the sum of the PSS then has 4 items subtracted so that a score of 0 (instead of 4) indicates that there are no psychotic symptoms. In doing this, the range for the PSS becomes 0 to 24), with larger values indicating more positive psychotic symptoms.

The measure is the change score of PSS total day 1 less PSS total Day 9. 0 indicates no change, where as positive numbers indicate a decrease in psychotic symptoms.

Outcome measures

Measure	Mifepristone n=3 Participants Receive 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo n=5 Participants Receive placebo rather than mifepristone Placebo: Placebo medication
Change in Psychotic Symptoms Subscale (PSS) of the Brief Psychiatric Rating Scale (BPRS)	.000 units on a scale Standard Deviation 2.6	1.00 units on a scale Standard Deviation .625

PRIMARY outcome

Timeframe: Day 1 to Day 9 difference

Population: Change in cortisol from Day 1 to Day 9

The reported value is the difference in mean evening cortisol from baseline to Day 9 The mean evening cortisol is calculated from the hourly cortisol value taken from 1800 hrs to 0100 hrs for both time points. The outcome measure is the difference of mean evening cortisol from Day 9 less the mean evening cortrisol from baseline. Negative values indicate a reduction in cortisol levels at Day 9, whereas positive values indicate an increase in cortisol at Day 9. Serum cortisol levels are reported in ug/dL

Outcome measures

Measure	Mifepristone n=3 Participants Receive 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo n=5 Participants Receive placebo rather than mifepristone Placebo: Placebo medication
Change in Mean Cortisol Level	-3.96 ug/dL Standard Deviation 2.4	.285 ug/dL Standard Deviation .95

SECONDARY outcome

Timeframe: Day 23

Time 1 (baseline) = Difference in cortisol level from Day 1 (pre-florinef mean evening cortisol) at Baseline less Day 2 (post-florinef mean evening cortisol) at baseline

Time 2 (post- mife or placebo treatment) = Difference in cortisol level from Day 22 (pre-florinef mean evening cortisol) and Day 23 (post-florinef mean evening cortisol level).

All measurements were the percent change in mean cortisol level from 6 pm to 10 pm. Cortisol levels are expressed as ug/dL

Percent change in cortisol decrease between Time 2 and Time 1 post florinef should be greater with mifepristone than placebo, reflecting enhanced mineralocorticoid receptor activity.

Outcome measures

Measure	Mifepristone n=2 Participants Receive 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo n=5 Participants Receive placebo rather than mifepristone Placebo: Placebo medication
% Change in Mean Evening Pre- and Post- Florinef Cortisol After Treatment With Either Mifepristone or Placebo	14 percentage change Standard Deviation .13	-.04 percentage change Standard Deviation .19

Adverse Events

Mifepristone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mifepristone n=4 participants at risk Receive 600 or 1200 mg/ day of mifepristone for 8 days Mifepristone (RU-486)	Placebo n=6 participants at risk Receive placebo rather than mifepristone Placebo: Placebo medication
Psychiatric disorders Psychaitric decompensation requiring hospitalization	0.00% 0/4 • Adverse events were gather while participating in the protocol, approximately 2 weeks Information on other adverse events was not readily available at time of reporting.	16.7% 1/6 • Number of events 1 • Adverse events were gather while participating in the protocol, approximately 2 weeks Information on other adverse events was not readily available at time of reporting.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alan Schatzberg

Stanford University

Phone: 650-723-6811

Email: afschatz@stanford.edu

Results disclosure agreements

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