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Sponsored by: |
Stanford University |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00867360 |
The purpose of this research study is to see how certain hormones cause changes in mood and thinking in some depressed patients and to determine the effectiveness of mifepristone in treating some forms of depression.
This study is conducted in conjunction with an observational study "Clinical and Biological Characteristics of Psychotic Depression".
Condition | Intervention | Phase |
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Affective Disorders, Psychotic Depressive Disorder |
Drug: Mifepristone (RU-486) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression |
Estimated Enrollment: | 50 |
Study Start Date: | August 2005 |
Study Completion Date: | May 2009 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 21 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Inclusion criteria for PMD (individuals with Psychotic Major Depression) are as follows:
Exclusion Criteria:Exclusion criteria for PMDs are as follows:
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Fredric B Kraemer | Stanford University |
Responsible Party: | Stanford University School of Medicine ( Anna Lembke, Principal Investigator ) |
Study ID Numbers: | SU-02262009-1838 |
Study First Received: | March 20, 2009 |
Last Updated: | June 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00867360 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Depression Contraceptive Agents Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Mifepristone Depressive Disorder, Major Contraceptives, Postcoital Depressive Disorder Hormones |
Behavioral Symptoms Schizophrenia Affective Disorders, Psychotic Dopamine Mental Disorders Mood Disorders Psychotic Disorders Dopamine Agents Epinephrine Schizophrenia and Disorders with Psychotic Features |
Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Abortifacient Agents Menstruation-Inducing Agents |
Contraceptives, Oral, Synthetic Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Abortifacient Agents, Steroidal Disease Depression Mifepristone Depressive Disorder Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions Behavioral Symptoms Mood Disorders |