Treatment of Psychotic Major Depression With Mifepristone

This study has been terminated.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00867360
First received: March 20, 2009
Last updated: June 10, 2009
Last verified: June 2009
  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:

  1. DSM IV diagnosis of Major Depressive Disorder with psychotic features, Bipolar II Disorder with psychotic features in a major depressive episode.
  2. 21-item HAM-D score greater than or equal to 21.
  3. Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
  4. Between 21 - 85 years of age.
  5. 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.
  6. 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.
  7. Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
  8. 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:

  1. ECT in the 6 months prior to the study.
  2. Abuse of drugs or alcohol in the 6 months prior to study.
  3. Unstable or untreated hypertension, cardiovascular disease.
  4. If participating in the blood draw portion of the protocol, endocrine disorders are exclusionary.
  5. Use of additional prescription medications, street drugs, or alcohol during the week before the study.
  6. Previous mifepristone failure or non-response.
  7. Any Axis II diagnosis or traits which would make participation in the study difficult.
  8. Current pregnancy or lactation.
  Contacts and Locations
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, see Learn About Clinical Studies.

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 July 29, 2014