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Treatment of Schizoaffective Disorder Using Mifepristone

This study has been terminated.
(Lack of funding.)
Sponsor:
Collaborator:
Pritzker Family Foundation
Information provided by (Responsible Party):
Jennifer Keller, Stanford University
ClinicalTrials.gov Identifier:
NCT00725270
First received: July 28, 2008
Last updated: February 1, 2017
Last verified: February 2017
  Purpose
This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Treatment of Schizoaffective Disorder Using Mifepristone

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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

  • 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.


Enrollment: 12
Study Start Date: April 1998
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725270

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

Responsible Party: Jennifer Keller, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00725270     History of Changes
Other Study ID Numbers: SU-06012008-1191
76458
Study First Received: July 28, 2008
Results First Received: October 11, 2016
Last Updated: February 1, 2017

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Psychotic Disorders
Mental Disorders
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mifepristone
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

ClinicalTrials.gov processed this record on April 26, 2017