Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

Major Depressive Disorder Clinical Trial

Official title:

Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01957501
• Other study ID #: Ridge II
• Status: Terminated
• Phase: N/A
• First received: September 10, 2013
• Last updated: April 6, 2017
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: March 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

Inclusion of Major Depressive Disorder Participants:

1. Male and female patients between the ages of 13 and 17 years

2. Participants must be able to give informed assent, and parent(s)/guardian(s) must be able to give informed permission for study participation

3. Diagnosis of MDD or depression not otherwise specified, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-TR criteria (DSM-IV-TR)

4. Current mood state depressed for > 2 weeks

Inclusion of Bipolar Disorder Participants:

1. Male and female patients between the ages of 13 and 17 years

2. Participants must be able to give informed assent, and parent (s)/guardian (s) must be able to give informed permission for study participation

3. Diagnosis of Bipolar I Disorder, Bipolar II Disorder, or not otherwise specified, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-TR criteria

4. Current mood state depressed for > 2 weeks

Inclusion of Healthy Control Participants:

1. Males and females between the ages of 13 and 17 years

2. Participants must not meet DSM-IV-TR diagnostic criteria for a psychiatric or substance abuse disorder

3. Participants must be able to give informed assent and parent (s)/guardian (s) must be able to give informed permission for study participation

Exclusion Criteria:

Exclusion of Major Depressive Disorder and Bipolar Disorder Participants:

1. Meet the DSM-IV criteria for substance abuse or dependence in the last month

2. History of fainting or other significant adverse event during blood draws in the past

3. Dysthymia

4. Daily use of oral or inhaled steroids

5. High risk of suicidal behaviors, homicidal behaviors, or self-harm

6. A medical condition, such as Addison's Disease, which is highly likely to influence the inflammatory or HPA responses

Exclusion of Healthy Control Participants:

1. Clinically significant psychiatric or substance abuse disorder

2. Unstable medical or neurological illness

3. History of fainting or other significant adverse event during blood draws in the past

4. Daily use of oral or inhaled steroids

5. A medical condition, such as Addison's Disease, which is highly likely to influence the inflammatory or HPA responses

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Serum Biomarkers

Intervention

Other:
• MDDScoreTM
The child will receive a single blood draw (about 10 mL).

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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. — View Citation

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. — View Citation

McEwen BS. Effects of adverse experiences for brain structure and function. Biol Psychiatry. 2000 Oct 15;48(8):721-31. — View Citation

Murray, CJL, Lopez, AD (Eds), The Global Burden of Disease, Cambridge Mass., Harvard University Press, 1996.

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. — View Citation

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.

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

Shelton RC. The molecular neurobiology of depression. Psychiatr Clin North Am. 2007 Mar;30(1):1-11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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