Trial Outcomes & Findings for Treatment of Schizoaffective Disorder Using Mifepristone (NCT NCT00725270)

NCT ID: NCT00725270

Last Updated: 2017-03-24

Results Overview

Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 12 participants
• Primary outcome timeframe: 8 days
• Results posted on: 2017-03-24

Participant Flow

Participant milestones

Measure	Placebo Patients will be randomized to placebo	Mifepristone Patients will be randomized to mifepristone
Overall Study STARTED	5	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Schizoaffective Disorder Using Mifepristone

Baseline characteristics by cohort

Measure	Placebo n=5 Participants Patients will be randomized to placebo	Mifepristone n=7 Participants Patients will be randomized to mifepristone	Total n=12 Participants Total of all reporting groups
Age, Continuous	36.4 years STANDARD_DEVIATION 15.9 • n=5 Participants	27.29 years STANDARD_DEVIATION 8.6 • n=7 Participants	31.08 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 days

Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms

Outcome measures

Measure	Placebo n=5 Participants Patients will be randomized to placebo	Mifepristone n=7 Participants Patients will be randomized to mifepristone
Change in Positive Psychotic Symptoms Over the Course of Treatment Baseline PSS Scores	12.0 units on a scale Standard Deviation 5.2	7.57 units on a scale Standard Deviation 3.5
Change in Positive Psychotic Symptoms Over the Course of Treatment Day 9 PSS scores	11.0 units on a scale Standard Deviation 6.4	6.0 units on a scale Standard Deviation 4.4

PRIMARY outcome

Timeframe: Baseline and Day 9

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.

Outcome measures

Measure	Placebo n=5 Participants Patients will be randomized to placebo	Mifepristone n=7 Participants Patients will be randomized to mifepristone
Change in Mood Symptoms Baseline	26.2 units on a scale Standard Deviation 10.3	24.86 units on a scale Standard Deviation 4.0
Change in Mood Symptoms Day 9	19.0 units on a scale Standard Deviation 8.3	13.57 units on a scale Standard Deviation 5.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mifepristone

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

Alan Schatzberg

Stanford University

Phone: 650-723-8331

Email: afschatz@stanford.edu

Results disclosure agreements

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