Serum Markers as a Bioassay for Unipolar Depression
Completed
- Conditions
- Major Depression
- Registration Number
- NCT00825799
- Brief Summary
The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
- Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above).
- Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis.
- Rheumatoid arthritis, lupus, or other condition associated with increased inflammation.
- Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis.
- A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses.
- Pregnancy.
- Meets DSM-IV criteria for substance abuse or dependence in the last month.
- Regular cigarette smoking.
- History of fainting or other significant adverse event during blood drawing in the past.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Protein biomarker MDDScore. 0 weeks
- Secondary Outcome Measures
Name Time Method Score on Hamilton Depression Rating Scale (HDRS). 0 weeks
Trial Locations
- Locations (1)
Steward St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States