Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 13 - 21 |
| Updated: | 4/21/2016 |
| Start Date: | July 2013 |
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.
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
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