Treatment of Schizoaffective Disorder Using Mifepristone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725270
Recruitment Status : Terminated (Lack of funding.)
First Posted : July 30, 2008
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Pritzker Family Foundation
Information provided by (Responsible Party):
Jennifer Keller, Stanford University

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

Condition or disease Intervention/treatment Phase
Psychotic Disorders Depressive Disorder, Major Depressive Disorder Drug: Mifepristone Drug: Placebo Oral Tablet Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Schizoaffective Disorder Using Mifepristone
Study Start Date : April 1998
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725270

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Pritzker Family Foundation
Study Director: Jennifer Keller Stanford University

Responsible Party: Jennifer Keller, Principle Investigator, Stanford University Identifier: NCT00725270     History of Changes
Other Study ID Numbers: SU-06012008-1191
First Posted: July 30, 2008    Key Record Dates
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Depressive Disorder
Psychotic Disorders
Mental Disorders
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents