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:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-24 @ 1:20 PM
NCT ID:
NCT00576095
Eligibility Criteria:
Inclusion Criteria:Inclusion criteria for PMD (individuals with Psychotic Major Depression) and NPMDs (individuals with Non-Psychotic Major Depression) are as follows:
1. DSM IV diagnosis of Major Depressive Disorder with or without psychotic features, Bipolar II Disorder with or without 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. 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.
6. Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
7. Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder(OCD) will be an exclusion criteria.
Inclusion criteria for healthy controls are as follows:
1\. Between 21 - 85 years of age. 2. Taking no medications 3. Have a HAM-D score of less than or equal to 5. Exclusion Criteria:Exclusion criteria for PMDs and NPMDs are as follows:
1. ECT in the 4 months prior to the study.
2. Abuse of drugs or alcohol in the 6 months prior to study.
3. Unstable or untreated hypertension, or 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. Any Axis II diagnosis or traits which would make participation in the study difficult.
7. Current pregnancy or lactation.
Exclusion criteria for healthy controls:
1. Personal history of Axis I or Axis II disorders.
2. Active unstable medical problems.
3. Abuse of drugs or alcohol in the 6 months prior to study.
4. Use of additional prescription medications, street drugs, or alcohol during the week before the study.
5. Currently pregnant or lactating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00576095
Study Brief:
Protocol Section:
NCT00576095