Exploring a Potential Blood Test to Diagnose Major Depressive Disorder (Bio-TestMDD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00705185|
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : June 8, 2010
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.
|Condition or disease|
|Major Depressive Disorder|
This proposed study will be an ancillary study to clinical trial NCT00555997 (www.clinicaltrials.gov) entitled: "A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Sequential Trial of Ziprasidone as Monotherapy for Major Depressive Disorder" (MDD)." Precision Human Biolaboratory ("PHB") is attempting to develop a proprietary blood test intended to potentially serve as a biological marker ("bio-marker") for MDD. Specifically, PHB's research team will employ a unique approach towards developing a diagnostic test for MDD: measures from multiple blood-based biological markers will be obtained from patients with MDD and then analyzed with the use of several interrelated algorithms in order to derive a single biological measure ("bio-marker") with a high predictive value for MDD. PHBs' test panel of blood-based biological markers will consist of a number of cytokines, stress related hormones, and binding proteins that have each been linked to MDD. This innovative test panel is expected to provide general practice physicians with a tool to more accurately identify and classify patients with MDD which, in turn, could potentially , allow for the more effective monitoring of pharmacotherapy (antidepressant drug therapy). Thus, the development of a highly reliable biomarker for MDD could improve the standard of care for depression.
For this ancillary study, 120 antidepressant-free outpatients with MDD who have been deemed eligible to participate in trial NCT00555997 will be recruited from participating centers. Participating subjects will undergo a blood draw during the baseline visit for NCT00555997. Values obtained will be compared with 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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Observational Model:||Case Control|
|Official Title:||Exploring Potential Serum/Plasma-Based Biomarkers as a Test for Major Depressive Disorder Diagnostics ("Bio-Test MDD")|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Adults with Major Depressive Disorder- as defined by the criteria in the DSM-IV
Healthy Controls- research subjects who have not met criteria for any lifetime Axis-I disorder (DSM-IV)
- 16 Biological Markers; Group comparison between adults with Major Depressive Disorder and healthy controls [ Time Frame: Screen visit ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705185
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|United States, Illinois|
|Psychiatric Medicine Associates, L.L.C.|
|Chicago, Illinois, United States, 60025|
|United States, Massachusetts|
|Massachusetts General Hosptial|
|Boston, Massachusetts, United States, 02114|
|Cambridge Health Alliance|
|Cambridge, Massachusetts, United States, 02139|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||George I Papakostas, M.D.||Massachusetts General Hospital|