Treatment of Psychotic Major Depression With Mifepristone

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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".

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Mifepristone

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.