Serum Markers as a Bioassay for Unipolar Depression
Validation of Serum Markers as a Bioassay for Unipolar Depression
1 other identifier
observational
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2007
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 19, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJanuary 3, 2014
June 1, 2013
3.5 years
January 19, 2009
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Protein biomarker MDDScore.
0 weeks
Secondary Outcomes (1)
Score on Hamilton Depression Rating Scale (HDRS).
0 weeks
Study Arms (2)
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.
Eligibility Criteria
Subjects are recruited from the community by advertisement.
You may qualify if:
- Aged 18 to 60.
- Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent.
- item Hamilton Depression rating scale score greater than 18.
- Capable of providing informed consent.
- Has an established residence and phone number.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Biospecimen
serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E. Henry, MD
Steward St. Elizabeth's Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2009
First Posted
January 21, 2009
Study Start
November 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 3, 2014
Record last verified: 2013-06