Depression Clinical Trial
Official title:
Hypothalamic-Pituitary-Adrenal (HPA)/ Dopamine Axis in Psychotic Depression
Verified date | March 2014 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
The primary objective of this study is to investigate the relationships among findings in structural and functional neuroimaging, cognitive testing and HPA (hypothalamic-pituitary-adrenal) axis dysregulation in psychotic depression.
Status | Completed |
Enrollment | 73 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cortisol | Hourly serum cortisol | baseline | No |
Secondary | Cognitive function | Standard domains - including verbal memory, executive functioning, attention | Baseline | No |
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