Treatment of Schizoaffective Disorder Using Mifepristone

February 1, 2017 updated by: Jennifer Keller, Stanford University
This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Pritzker Family Foundation

Investigators

  • Study Director: Jennifer Keller, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

February 1, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-06012008-1191
  • 76458

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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