Treatment of Psychotic Major Depression With Mifepristone
Condition: Affective Disorders, Psychotic; Depressive Disorder
MeSH terms: Depressive Disorder; Mental Disorders; Psychotic Disorders; Mood Disorders; Affective Disorders, Psychotic
Intervention: Mifepristone (RU-486); Placebo
Intervention description: Placebo medication
Intervention MeSH terms: Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 21 Years
Maximum age: 85 Years
Healthy volunteers: No

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".
    

Eligibility 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.