500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages: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 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.
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Trial ID: NCT00825799
Accepting Healthy Volunteers