Major Depressive DisorderNCT01957501
Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel
An observational study of Major Depressive Disorder and Bipolar Disorder, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder, Serum Biomarkers
- What is being tested?
- MDDScoreTM
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants who respond to recruitment flyers displayed within the community.
Who may be able to join
- Male and female patients between the ages of 13 and 17 years
- Participants must be able to give informed assent, and parent(s)/guardian(s) must be able to give informed permission for study participation
- 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)
- Current mood state depressed for > 2 weeks
- Male and female patients between the ages of 13 and 17 years
- Participants must be able to give informed assent, and parent (s)/guardian (s) must be able to give informed permission for study participation
Show all 11Show fewer
- 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
- Current mood state depressed for > 2 weeks
- Males and females between the ages of 13 and 17 years
- Participants must not meet DSM-IV-TR diagnostic criteria for a psychiatric or substance abuse disorder
- Participants must be able to give informed assent and parent (s)/guardian (s) must be able to give informed permission for study participation
Who cannot join
- Exclusion of Major Depressive Disorder and Bipolar Disorder Participants:
- Meet the DSM-IV criteria for substance abuse or dependence in the last month
- History of fainting or other significant adverse event during blood draws in the past
- Dysthymia
- Daily use of oral or inhaled steroids
- High risk of suicidal behaviors, homicidal behaviors, or self-harm
Show all 12Show fewer
- A medical condition, such as Addison's Disease, which is highly likely to influence the inflammatory or HPA responses
- Clinically significant psychiatric or substance abuse disorder
- Unstable medical or neurological illness
- History of fainting or other significant adverse event during blood draws in the past
- Daily use of oral or inhaled steroids
- A medical condition, such as Addison's Disease, which is highly likely to influence the inflammatory or HPA responses
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- MDDScoreTM
- Keywords
- Major Depressive Disorder, Bipolar Disorder, Adolescents, Biomarker
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDDScoreTMOther
The child will receive a single blood draw (about 10 mL).
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Disorder Participants | Not described Receives: Other: MDDScoreTM | |
| Bipolar Disorder Participants: | Not described Receives: Other: MDDScoreTM | |
| Healthy Control Participants | Not described Receives: Other: MDDScoreTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker for Major Depressive Disorder (MDD) and Bipolar Disorder in Adolescents
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionMar 2016
Why it stopped: Funding has been terminated for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Kondo, MD, University of Utah
- Investigators
- Douglas Kondo, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957501
- Sponsor's protocol ID
- Ridge II
- Status last verified
- Apr 2017
- First submitted
- 10 Sep 2013
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31.
PubMed 11480881Kendler KS, Karkowski LM, Prescott CA. Causal relationship between stressful life events and the onset of major depression. Am J Psychiatry. 1999 Jun;156(6):837-41. doi: 10.1176/ajp.156.6.837.
PubMed 10360120McEwen BS. Effects of adverse experiences for brain structure and function. Biol Psychiatry. 2000 Oct 15;48(8):721-31. doi: 10.1016/s0006-3223(00)00964-1.
PubMed 11063969Shelton RC. The molecular neurobiology of depression. Psychiatr Clin North Am. 2007 Mar;30(1):1-11. doi: 10.1016/j.psc.2006.12.005.
PubMed 17362799Pillay SS, Renshaw PF, Bonello CM, Lafer BC, Fava M, Yurgelun-Todd D. A quantitative magnetic resonance imaging study of caudate and lenticular nucleus gray matter volume in primary unipolar major depression: relationship to treatment response and clinical severity. Psychiatry Res. 1998 Dec 14;84(2-3):61-74. doi: 10.1016/s0925-4927(98)00048-1.
PubMed 10710164Iosifescu DV, Papakostas GI, Lyoo IK, Lee HK, Renshaw PF, Alpert JE, Nierenberg A, Fava M. Brain MRI white matter hyperintensities and one-carbon cycle metabolism in non-geriatric outpatients with major depressive disorder (Part I). Psychiatry Res. 2005 Dec 30;140(3):291-9. doi: 10.1016/j.pscychresns.2005.09.003.
PubMed 16298109Renshaw, 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Depression and Bipolar Disorder in Adolescents Using a Biomarker Panel
- ClinicalTrials.gov ID
- NCT01957501
- Acronym / sponsor ID
- Ridge II
- Keywords
- Major Depressive Disorder, Bipolar Disorder, Adolescents, Biomarker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding has been terminated for this study.
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Disorder Participants | – | Other: MDDScoreTM |
| Bipolar Disorder Participants: | – | Other: MDDScoreTM |
| Healthy Control Participants | – | Other: MDDScoreTM |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants who respond to recruitment flyers displayed within the community.
Key inclusion criteria (11 listed)
- Male and female patients between the ages of 13 and 17 years
- Participants must be able to give informed assent, and parent(s)/guardian(s) must be able to give informed permission for study participation
- 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)
- Current mood state depressed for > 2 weeks
- Male and female patients between the ages of 13 and 17 years
Key exclusion criteria (12 listed)
- Meet the DSM-IV criteria for substance abuse or dependence in the last month
- History of fainting or other significant adverse event during blood draws in the past
- Dysthymia
- Daily use of oral or inhaled steroids
- High risk of suicidal behaviors, homicidal behaviors, or self-harm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDDScoreTMThe child will receive a single blood draw (about 10 mL). | Other | Bipolar Disorder Participants:, Healthy Control Participants, Major Depressive Disorder Participants |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Funding has been terminated for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 11480881Greden JF. The burden of disease for treatment-resistant depression. J Clin Psychiatry. 2001;62 Suppl 16:26-31.
- Background: PubMed 10360120Kendler KS, Karkowski LM, Prescott CA. Causal relationship between stressful life events and the onset of major depression. Am J Psychiatry. 1999 Jun;156(6):837-41. doi: 10.1176/ajp.156.6.837.
- Background: PubMed 11063969McEwen BS. Effects of adverse experiences for brain structure and function. Biol Psychiatry. 2000 Oct 15;48(8):721-31. doi: 10.1016/s0006-3223(00)00964-1.
- Background: PubMed 17362799Shelton RC. The molecular neurobiology of depression. Psychiatr Clin North Am. 2007 Mar;30(1):1-11. doi: 10.1016/j.psc.2006.12.005.
- Background: PubMed 10710164Pillay SS, Renshaw PF, Bonello CM, Lafer BC, Fava M, Yurgelun-Todd D. A quantitative magnetic resonance imaging study of caudate and lenticular nucleus gray matter volume in primary unipolar major depression: relationship to treatment response and clinical severity. Psychiatry Res. 1998 Dec 14;84(2-3):61-74. doi: 10.1016/s0925-4927(98)00048-1.
- Background: PubMed 16298109Iosifescu DV, Papakostas GI, Lyoo IK, Lee HK, Renshaw PF, Alpert JE, Nierenberg A, Fava M. Brain MRI white matter hyperintensities and one-carbon cycle metabolism in non-geriatric outpatients with major depressive disorder (Part I). Psychiatry Res. 2005 Dec 30;140(3):291-9. doi: 10.1016/j.pscychresns.2005.09.003.
- BackgroundRenshaw, 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.
- BackgroundMurray, CJL, Lopez, AD (Eds), The Global Burden of Disease, Cambridge Mass., Harvard University Press, 1996.
- BackgroundRobins LN, Regier DA (Eds). Psychiatric Disorders in America, The Epidemiologic Catchment Area Study, 1990; New York: The Free Press. Items 1 - 20 of 204
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Kondo, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bipolar Disorder, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding has been terminated for this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker for Major Depressive Disorder (MDD) and Bipolar Disorder in Adolescents (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01957501, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.