Serum Markers as a Bioassay for Unipolar Depression

NCT ID: NCT00825799

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-05-31

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.

Conditions

Major Depression

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Major Depressive Disorder

Adults with major depressive disorder who are experiencing a current depressive episode.

No interventions assigned to this group

Healthy controls

Individuals without any Axis I psychiatric diagnosis who are matched to depressed subjects by age and sex.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ridge Diagnostics Inc.

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael E. Henry, MD

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's Medical Center

Locations

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

00435

Identifier Type: -

Identifier Source: org_study_id