Treatment of Schizoaffective Disorder Using Mifepristone
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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. |
| ClinicalTrials.gov Identifier: NCT00725270 |
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Recruitment Status :
Terminated
(Lack of funding.)
First Posted : July 30, 2008
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
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Sponsor:
Stanford University
Collaborator:
Pritzker Family Foundation
Information provided by (Responsible Party):
Jennifer Keller, Stanford University
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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 |
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 |
| Actual Primary Completion Date : | May 2009 |
| Actual Study Completion Date : | May 2009 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Mifepristone
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Patients will be randomized to placebo
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Drug: Placebo Oral Tablet
Placebo comparator |
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Experimental: Mifepristone
Patients will be randomized to mifepristone
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Drug: Mifepristone
600 mg of mifepristone |
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.
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, Older Adult) |
| 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.
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 ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jennifer Keller, Principle Investigator, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00725270 |
| Other Study ID Numbers: |
SU-06012008-1191 76458 |
| 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:
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Disease Depressive Disorder Depression Mental Disorders Psychotic 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 Contraceptive Agents, Hormonal Menstruation-Inducing Agents |