Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel
Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel
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.
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