Treatment of Schizoaffective Disorder Using Mifepristone

Depressive Disorder Clinical Trial

Official title:

Treatment of Schizoaffective Disorder Using Mifepristone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00725270
• Other study ID #: SU-06012008-1191
• Secondary ID: 76458
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 28, 2008
• Last updated: March 12, 2014
• Start date: April 1998
• Est. completion date: May 2009

Study information

• Verified date: March 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Mifepristone

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Pritzker Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mood and psychotic symptoms over the course of treatment		8 days	No