Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

NCT01957501 | Terminated

• 1 other identifier: Ridge II
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Bipolar Disorder; Serum Biomarkers

Keywords

Major Depressive Disorder; Bipolar Disorder; Adolescents; Biomarker

Outcome Measures

Primary Outcomes (1)

• Biomarker for Major Depressive Disorder (MDD) and Bipolar Disorder in Adolescents

  The MDDScore™ will determine the biomarker of Major Depressive Disorder (MDD) and Bipolar Disorder. The MDDScore™ 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 MDDScore™ 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 MDDScore™ is 10, the patient has a greater than 90% likelihood of having MDD. An MDDScore™ 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

Study Arms (3)

Major Depressive Disorder Participants

Other: MDDScoreTM

Bipolar Disorder Participants:

Other: MDDScoreTM

Healthy Control Participants

Other: MDDScoreTM

Interventions

MDDScoreTM OTHER

The child will receive a single blood draw (about 10 mL).

Bipolar Disorder Participants:; Healthy Control Participants; Major Depressive Disorder Participants

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants who respond to recruitment flyers displayed within the community.

You may not qualify if:

• Meet the DSM-IV criteria for substance abuse or dependence in the last month
• History of fainting or other significant adverse event during blood draws in the past
• Dysthymia
• Daily use of oral or inhaled steroids
• High risk of suicidal behaviors, homicidal behaviors, or self-harm
• A medical condition, such as Addison's Disease, which is highly likely to influence the inflammatory or HPA responses
• Clinically significant psychiatric or substance abuse disorder
• Unstable medical or neurological illness
• History of fainting or other significant adverse event during blood draws in the past
• Daily use of oral or inhaled steroids
• A medical condition, such as Addison's Disease, which is highly likely to influence the inflammatory or HPA responses

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (9)

• Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31.

  PMID: 11480881 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.

  PMID: 10360120 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.

  PMID: 11063969 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.

  PMID: 17362799 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.

  PMID: 10710164 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.

  PMID: 16298109 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

  BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Douglas Kondo, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: October 8, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)