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Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel

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ClinicalTrials.gov Identifier: NCT01957501
Recruitment Status : Terminated (Funding has been terminated for this study.)
First Posted : October 8, 2013
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Douglas Kondo, MD, University of Utah

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
Major Depressive Disorder Bipolar Disorder Serum Biomarkers Other: MDDScoreTM

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 : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort 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).




Primary Outcome Measures :
  1. Biomarker for Major Depressive Disorder (MDD) and Bipolar Disorder in Adolescents [ Time Frame: 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.



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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants who respond to recruitment flyers displayed within the community.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957501


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Douglas Kondo, M.D. University of Utah

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

Responsible Party: Douglas Kondo, MD, MD, University of Utah
ClinicalTrials.gov Identifier: NCT01957501     History of Changes
Other Study ID Numbers: Ridge II
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017

Keywords provided by Douglas Kondo, MD, University of Utah:
Major Depressive Disorder
Bipolar Disorder
Adolescents
Biomarker

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders