Exploring a Potential Blood Test to Diagnose Major Depressive Disorder

NCT00705185 | Completed

• 1 other identifier: 2007-P-002525
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to develop a blood test for major depression and measure the effects of ziprasidone monotherapy on these markers. Specific Aim: Using a multiplex biomarker assay we will measure levels of 16 biomarkers in patients with MDD enrolled in this ancillary study (adjunct to study NCT00555997) and compare these results to those of healthy controls" (defined as research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)) from an existing dataset at PHB.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Blood Test

Outcome Measures

Primary Outcomes (1)

• 16 Biological Markers; Group comparison between adults with Major Depressive Disorder and healthy controls

  Screen visit

Study Arms (2)

1

Adults with Major Depressive Disorder- as defined by the criteria in the DSM-IV

2

Healthy Controls- research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with Major Depressive Disorder (DSM-IV)

You may qualify if:

• Age 18-65.
• Written informed consent.
• MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998).
• Quick Inventory of Depressive Symptomatology - Self-Rated (QIDS-SR- Trivedi et al, 2004) score of at least 10 at both screen and baseline visits.

You may not qualify if:

• Pregnant women.
• Women of child bearing potential who are not using a medically accepted means of contraception (to include oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy).
• Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout.
• Patients who no longer meet DSM-IV criteria for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline.
• Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D.
• Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease.
• Patients who meet criteria for alcohol or substance dependence, active within the last month.
• Any bipolar disorder (current or past).
• Any psychotic disorder (current or past).
• Psychotic features in the current episode or a history of psychotic features.
• History of a seizure disorder.
• Clinical or laboratory evidence of untreated hypothyroidism.
• Patients requiring excluded medications (see table 1 for details).
• Prior course of ziprasidone, or intolerance to ziprasidone at any dose.
• Any investigational psychotropic drug within the last 3 months.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Precision Human Biolaboratories: collaborator
• Cambridge Health Alliance: collaborator
• University of Connecticut: collaborator
• Vanderbilt University: collaborator
• Psychiatric Medicine Associates, L.L.C.: collaborator

Study Sites (5)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Psychiatric Medicine Associates, L.L.C.

Chicago, Illinois, 60025, United States

Location

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• George I Papakostas, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 8, 2010

Record last verified: 2010-06

Locations

US (5)