Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

Sponsor

University of Utah (Other)

Overall Status

Terminated

CT.gov ID

NCT01957501

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Bipolar Disorder Serum Biomarkers	Other: MDDScoreTM

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Major Depressive Disorder Participants	Other: MDDScoreTM The child will receive a single blood draw (about 10 mL).
Bipolar Disorder Participants:	Other: MDDScoreTM The child will receive a single blood draw (about 10 mL).
Healthy Control Participants	Other: MDDScoreTM The child will receive a single blood draw (about 10 mL).

Arm

Intervention/Treatment

Major Depressive Disorder Participants

Other: MDDScoreTM

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

Bipolar Disorder Participants:

Other: MDDScoreTM

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

Healthy Control Participants

Other: MDDScoreTM

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

Outcome Measures

Primary Outcome Measures

Biomarker for Major Depressive Disorder (MDD) and Bipolar Disorder in Adolescents [4 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion of Major Depressive Disorder Participants:

Male and female patients between the ages of 13 and 17 years
Participants must be able to give informed assent, and parent(s)/guardian(s) must be able to give informed permission for study participation
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)
Current mood state depressed for > 2 weeks

Inclusion of Bipolar Disorder Participants:

Male and female patients between the ages of 13 and 17 years
Participants must be able to give informed assent, and parent (s)/guardian (s) must be able to give informed permission for study participation
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
Current mood state depressed for > 2 weeks

Inclusion of Healthy Control Participants:

Males and females between the ages of 13 and 17 years
Participants must not meet DSM-IV-TR diagnostic criteria for a psychiatric or substance abuse disorder
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:

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

Exclusion of Healthy Control Participants:

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