Treatment of Schizoaffective Disorder Using Mifepristone
Primary Purpose
Psychotic Disorders, Depressive Disorder, Major, Depressive Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders
Eligibility 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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Mifepristone
Arm Description
Patients will be randomized to placebo
Patients will be randomized to mifepristone
Outcomes
Primary Outcome Measures
Change in Positive Psychotic Symptoms Over the Course of Treatment
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00725270
First Posted
July 28, 2008
Last Updated
February 1, 2017
Sponsor
Stanford University
Collaborators
Pritzker Family Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00725270
Brief Title
Treatment of Schizoaffective Disorder Using Mifepristone
Official Title
Treatment of Schizoaffective Disorder Using Mifepristone
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding.
Study Start Date
April 1998 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Pritzker Family Foundation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Depressive Disorder, Major, Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will be randomized to placebo
Arm Title
Mifepristone
Arm Type
Experimental
Arm Description
Patients will be randomized to mifepristone
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Intervention Description
600 mg of mifepristone
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Change in Positive Psychotic Symptoms Over the Course of Treatment
Description
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
Time Frame
8 days
Title
Change in Mood Symptoms
Description
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.
Time Frame
Baseline and Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Keller
Organizational Affiliation
Stanford University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31307859
Citation
Cherian K, Schatzberg AF, Keller J. HPA axis in psychotic major depression and schizophrenia spectrum disorders: Cortisol, clinical symptomatology, and cognition. Schizophr Res. 2019 Nov;213:72-79. doi: 10.1016/j.schres.2019.07.003. Epub 2019 Jul 12.
Results Reference
derived
Learn more about this trial
Treatment of Schizoaffective Disorder Using Mifepristone
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