Serum Markers as a Bioassay for Unipolar Depression

Validation of Serum Markers as a Bioassay for Unipolar Depression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00825799

Enrollment

160

Registered

2009-01-21

Start date

2007-11-30

Completion date

2011-05-31

Last updated

2014-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

biomarker, depression, blood test

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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Protein biomarker MDDScore.	0 weeks

Secondary

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

Countries

United States

Outcome results