Treatment of Psychotic Major Depression With Mifepristone

Not Recruiting

Trial ID: 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".

Official Title

Hypothalamic-Pituitary-Adrenal (HPA)/Dopamine Axis in Psychotic Depression

Stanford Investigator(s)

Fredric Kraemer
Fredric Kraemer

Gerald M. Reaven, MD, Professor of Endocrinology, Emeritus


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

   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.


drug: Mifepristone (RU-486)

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lakshika Tennakoon