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NCT01957501 · ClinicalTrials.gov registry record
Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel
A clinical trial, sponsored by University of Utah.
- Terminated
- Registry status
- 75
- Enrollment target
NCT01957501: Clinical Trial study, sponsored by University of Utah.
NCT01957501 is a clinical trial that was terminated before completion, run by University of Utah. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01957501 was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- 75 participants
- Enrollment target
Study 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.
Primary Outcome
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 patie
Interventions
- OTHER MDDScoreTM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-03 |
Why NCT01957501 stopped before completion
NCT01957501 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which MDDScoreTM is the first listed.
NCT01957501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01957501 about?
NCT01957501 is a clinical study titled "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 sta...
What is the current status of trial NCT01957501?
This trial is currently terminated. The enrollment target is 75 participants. The study started on 2013-07. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01957501?
The interventions under investigation include: MDDScoreTM (OTHER).
Who is sponsoring clinical trial NCT01957501?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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