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Completed

NCT Number: NCT00825799

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Protein biomarker MDDScore.

    Time frame: 0 weeks

Secondary outcomes

  1. Score on Hamilton Depression Rating Scale (HDRS).

    Time frame: 0 weeks

Sponsors and collaborators

Lead sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Other

Collaborators

  • Ridge Diagnostics Inc.

Registry information

Official study title

Validation of Serum Markers as a Bioassay for Unipolar Depression

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2009
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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