Treatment of Schizoaffective Disorder Using Mifepristone

Study Overview
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Brief Summary
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This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

Detailed Description
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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.

Official Title
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Treatment of Schizoaffective Disorder Using Mifepristone

Conditions
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Psychotic Disorders, Depressive Disorder, Major, Depressive Disorder

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will be randomized to placebo | Drug: Placebo Oral Tablet<br>* Placebo comparator<br>|
| Experimental: Mifepristone<br>Patients will be randomized to mifepristone | Drug: Mifepristone<br>* 600 mg of mifepristone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 days | 
| 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. | Baseline and Day 9 |