Treatment of Schizoaffective Disorder Using Mifepristone

Phase 2

Terminated

• Conditions: Depressive Disorder; Psychotic Disorders; Depressive Disorder, Major
• Interventions: Drug: Placebo Oral Tablet; Drug: Mifepristone

• Registration Number: NCT00725270
• Lead Sponsor: Stanford University

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 Timeline

• Study Start: 1998-04
• Study First Submitted: 2008-07-28
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-30
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2016-10-11
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Results First Posted: 2017-03-24
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	Patients will be randomized to placebo
Mifepristone	Mifepristone	Patients will be randomized to mifepristone

Primary Outcome Measures

Name	Time	Method
Change in Mood Symptoms	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	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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States