Treatment of Psychotic Major Depression With Mifepristone
This study has been terminated.
Sponsor:
Stanford University
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00867360
First received: March 20, 2009
Last updated: June 10, 2009
Last verified: June 2009
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Purpose
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 |
|---|---|---|
|
Affective Disorders, Psychotic Depressive Disorder |
Drug: Mifepristone (RU-486) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Change in psychotic symptoms
- Clinical improvement is associated with changes in cognition and HPA axis function (cortisol, ACTH)
Secondary Outcome Measures:
- Clinical improvement is associated with change in MR sensitivity
| 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) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 21 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:Inclusion criteria for PMD (individuals with Psychotic Major Depression) are as follows:
- DSM IV diagnosis of Major Depressive Disorder with psychotic features, Bipolar II Disorder with psychotic features in a major depressive episode.
- 21-item HAM-D score greater than or equal to 21.
- Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
- Between 21 - 85 years of age.
- Female patients of child bearing capacity with Psychotic Depression receiving treatment with mifepristone are required to use a double-barrier method of contraception or abstinence for the entire duration of the study as well as for thirty days after the last dose of Mifepristone is taken.
- If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
- Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
- Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder(OCD) will be an exclusion criteria.
Exclusion Criteria:Exclusion criteria for PMDs are as follows:
- ECT in the 6 months prior to the study.
- Abuse of drugs or alcohol in the 6 months prior to study.
- Unstable or untreated hypertension, cardiovascular disease.
- If participating in the blood draw portion of the protocol, endocrine disorders are exclusionary.
- Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- Previous mifepristone failure or non-response.
- Any Axis II diagnosis or traits which would make participation in the study difficult.
- Current pregnancy or lactation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867360
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Fredric B Kraemer | Stanford University |
More Information
No publications provided
| Responsible Party: | Anna Lembke, Principal Investigator, Stanford University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00867360 History of Changes |
| Other Study ID Numbers: | SU-02262009-1838 |
| Study First Received: | March 20, 2009 |
| Last Updated: | June 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Affective Disorders, Psychotic Depression Depressive Disorder Mental Disorders Psychotic Disorders 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 23, 2013