Treatment of Schizoaffective Disorder Using Mifepristone
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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 Depressive Disorder, Major |
Drug: Mifepristone |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treatment of Schizoaffective Disorder Using Mifepristone |
- Psychiatric Symptomatology
| Estimated Enrollment: | 30 |
| Study Start Date: | April 1998 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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 |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Study Director: | Jennifer Keller | Stanford University |
More Information
No publications provided
| Responsible Party: | Hugh Brent Solvason, Principal Investigator, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00725270 History of Changes |
| Other Study ID Numbers: | SU-06012008-1191, 76458 |
| Study First Received: | July 28, 2008 |
| Last Updated: | June 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Psychotic Disorders Mental Disorders Depressive Disorder, Major Mood Disorders Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features Mifepristone Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents |
ClinicalTrials.gov processed this record on May 16, 2013