Treatment of Schizoaffective Disorder Using Mifepristone
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Mood Symptoms
Study Overview
Brief Summary
This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo
Patients will be randomized to placebo
Intervention: Placebo Oral Tablet (Drug)
Mifepristone
Patients will be randomized to mifepristone
Intervention: Mifepristone (Drug)
Outcomes
Primary Outcomes
Change in Mood Symptoms
Time Frame: 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.
Change in Positive Psychotic Symptoms Over the Course of Treatment
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Jennifer Keller
Principle Investigator
Stanford University