Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT00867360
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00867360
Study Brief:
Protocol Section:
NCT00867360