Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

NCT ID: NCT01957501

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-03-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Major Depressive Disorder Participants

MDDScoreTM

Intervention Type: OTHER

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

Bipolar Disorder Participants:

MDDScoreTM

Intervention Type: OTHER

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

Healthy Control Participants

MDDScoreTM

Intervention Type: OTHER

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

Interventions

MDDScoreTM

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Douglas Kondo, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Kondo, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Other Identifiers

Ridge II

Identifier Type: -

Identifier Source: org_study_id