Serum Markers as a Bioassay for Unipolar Depression

Validation of Serum Markers as a Bioassay for Unipolar Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depression

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Steward St. Elizabeth's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects are recruited from the community by advertisement.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Major Depressive Disorder; Adults with major depressive disorder who are experiencing a current depressive episode.
Healthy controls; Individuals without any Axis I psychiatric diagnosis who are matched to depressed subjects by age and sex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Protein biomarker MDDScore.	0 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Score on Hamilton Depression Rating Scale (HDRS).	0 weeks

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Collaborators: Ridge Diagnostics Inc.
• Investigators: Principal Investigator: Michael E. Henry, MD, Steward St. Elizabeth's Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 19, 2009
• First Submitted That Met QC Criteria: January 19, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Estimate): January 3, 2014
• Last Update Submitted That Met QC Criteria: January 2, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: depression; biomarker; blood test
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 00435