Serum Markers as a Bioassay for Unipolar Depression

Major Depression Clinical Trial

Official title:

Validation of Serum Markers as a Bioassay for Unipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825799
• Other study ID #: 00435
• Status: Completed
• Phase: N/A
• First received: January 19, 2009
• Last updated: January 2, 2014
• Start date: November 2007
• Est. completion date: May 2011

Study information

• Verified date: June 2013
• Source: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Locations

Country	Name	City	State
United States	Steward St. Elizabeth's Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.	Ridge Diagnostics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein biomarker MDDScore.		0 weeks	No
Secondary	Score on Hamilton Depression Rating Scale (HDRS).		0 weeks	No