Official Title

Treatment of Schizoaffective Disorder Using Mifepristone
  • Phase

    Phase 2/Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    mifepristone ...
  • Study Participants

    12
This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.
You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.
Study Started
Apr 30
1998
Primary Completion
May 31
2009
Study Completion
May 31
2009
Results Posted
Mar 24
2017
Last Update
Mar 24
2017

Drug Mifepristone

600 mg of mifepristone

Drug Placebo Oral Tablet

Placebo comparator

Placebo Placebo Comparator

Patients will be randomized to placebo

Mifepristone Experimental

Patients will be randomized to mifepristone

Criteria

Inclusion Criteria:The subjects will be 30 inpatients or outpatients with schizoaffective disorder. Exclusion Criteria:Subjects must be between the ages of eighteen and seventy-five without major medical problems.

Summary

Placebo

Mifepristone

All Events

Event Type Organ System Event Term

Change in Positive Psychotic Symptoms Over the Course of Treatment

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

Placebo

Baseline PSS Scores

12.0
units on a scale (Mean)
Standard Deviation: 5.2

Day 9 PSS scores

11.0
units on a scale (Mean)
Standard Deviation: 6.4

Mifepristone

Baseline PSS Scores

7.57
units on a scale (Mean)
Standard Deviation: 3.5

Day 9 PSS scores

6.0
units on a scale (Mean)
Standard Deviation: 4.4

Change in Mood Symptoms

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.

Placebo

Baseline

26.2
units on a scale (Mean)
Standard Deviation: 10.3

Day 9

19.0
units on a scale (Mean)
Standard Deviation: 8.3

Mifepristone

Baseline

24.86
units on a scale (Mean)
Standard Deviation: 4.0

Day 9

13.57
units on a scale (Mean)
Standard Deviation: 5.5

Total

12
Participants

Age, Continuous

31.08
years (Mean)
Standard Deviation: 12.4

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

Placebo

Mifepristone