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Funding has been terminated for this study.
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Depression and bipolar disorder are major public health concerns for adolescents today. Teenage depression and bipolar disorder are associated with social isolation, family stress, school failure, substance abuse and suicide. Screening for depression and bipolar disorder so that treatment can be started early in the course of illness is an urgent public health priority. Many teens with bipolar disorder are incorrectly diagnosed as having unipolar depression. It is critical that adolescents receive proper screening and assessment that leads to an accurate diagnosis and treatment. An efficient, cost-effective, blood-based screening program could be performed on an annual or semi-annual basis to potentially detect depression and then differentiate between unipolar and bipolar depression. If this type of screening were able to detect a significant percentage of teens with depression or bipolar disorder, the positive impact on U.S. public health would be substantial. The purpose of this study is to conduct a pilot study to assess the probability of detecting adolescent unipolar and bipolar depression through blood samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Major Depressive Disorder Participants |
| ||
| Bipolar Disorder Participants: |
| ||
| Healthy Control Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDDScoreTM | Other | The child will receive a single blood draw (about 10 mL). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker for Major Depressive Disorder (MDD) and Bipolar Disorder in Adolescents | The MDDScoreâ„¢ will determine the biomarker of Major Depressive Disorder (MDD) and Bipolar Disorder. The MDDScoreâ„¢ is determined using nine blood based biomarkers (inflammatory markers [4], stress related hormones [2], neuroendocrine [1] and metabolic proteins [2]) on physiological pathways related to MDD. The test results for the MDDScoreâ„¢ range from 1 to 10. If the patient's score is 1, the patient has a less than 10% likelihood of having MDD. If the patient's MDDScoreâ„¢ is 10, the patient has a greater than 90% likelihood of having MDD. An MDDScoreâ„¢ of 5 or less is considered normal or negative and a score of 6 or more is considered "diseased" or positive. This same scoring system would hold true for classifying the likelihood of having bipolar disorder, as well. Test characteristics, such as sensitivity and specificity, are calculated based on this determination. | 4 years |
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Inclusion of Major Depressive Disorder Participants:
Inclusion of Bipolar Disorder Participants:
Inclusion of Healthy Control Participants:
Exclusion Criteria:
Exclusion of Major Depressive Disorder and Bipolar Disorder Participants:
Exclusion of Healthy Control Participants:
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Participants who respond to recruitment flyers displayed within the community.
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Kondo, M.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11480881 | Background | Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31. | |
| 10360120 | Background | Kendler KS, Karkowski LM, Prescott CA. Causal relationship between stressful life events and the onset of major depression. Am J Psychiatry. 1999 Jun;156(6):837-41. doi: 10.1176/ajp.156.6.837. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| 11063969 | Background | McEwen BS. Effects of adverse experiences for brain structure and function. Biol Psychiatry. 2000 Oct 15;48(8):721-31. doi: 10.1016/s0006-3223(00)00964-1. |
| 17362799 | Background | Shelton RC. The molecular neurobiology of depression. Psychiatr Clin North Am. 2007 Mar;30(1):1-11. doi: 10.1016/j.psc.2006.12.005. |
| 10710164 | Background | Pillay SS, Renshaw PF, Bonello CM, Lafer BC, Fava M, Yurgelun-Todd D. A quantitative magnetic resonance imaging study of caudate and lenticular nucleus gray matter volume in primary unipolar major depression: relationship to treatment response and clinical severity. Psychiatry Res. 1998 Dec 14;84(2-3):61-74. doi: 10.1016/s0925-4927(98)00048-1. |
| 16298109 | Background | Iosifescu DV, Papakostas GI, Lyoo IK, Lee HK, Renshaw PF, Alpert JE, Nierenberg A, Fava M. Brain MRI white matter hyperintensities and one-carbon cycle metabolism in non-geriatric outpatients with major depressive disorder (Part I). Psychiatry Res. 2005 Dec 30;140(3):291-9. doi: 10.1016/j.pscychresns.2005.09.003. |
| Background | Renshaw, PF, Bilello, JA , Pi, B. Multianalyte Biomarker Blood Test to Aid in Diagnosis,Treatment and Management of Major Depressive Disorder. Poster NR7-014, American Psychiatric Association Meeting, May 2009. |
| Background | Murray, CJL, Lopez, AD (Eds), The Global Burden of Disease, Cambridge Mass., Harvard University Press, 1996. |
| Background | Robins LN, Regier DA (Eds). Psychiatric Disorders in America, The Epidemiologic Catchment Area Study, 1990; New York: The Free Press. Items 1 - 20 of 204 |