Status:
COMPLETED
Serum Markers as a Bioassay for Unipolar Depression
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborating Sponsors:
Ridge Diagnostics Inc.
Conditions:
Major Depression
Eligibility:
All Genders
18-60 years
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00825799
Start Date
November 1 2007
End Date
May 1 2011
Last Update
January 3 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135