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Validation of Serum Markers as a Bioassay for Unipolar Depression

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Trial Conditions
  • Major Depression
What is the purpose of this trial?

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.

Date & Status


Who can Participate?


18  - 60 



Inclusion Criteria (Depressed):

- Aged 18 to 60.

- Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent.

- 21 item Hamilton Depression rating scale score greater than 18.

- Capable of providing informed consent.

- Has an established residence and phone number.

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

- Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol

- Rheumatoid arthritis, lupus, or other condition associated with increased

- 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

Gender: Both
Steward Physician(s)
  • Michael E. Henry, MD
  • St. Elizabeth's Medical Center - Completed
Physician Researcher

Investigator Name:

  • Michael E. Henry, MD

Other Information

Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: N/A
Trial ID: NCT00825799
Volunteers:  Accepting Healthy Volunteers

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