Characterization and Treatment of Adolescent Depression
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|ClinicalTrials.gov Identifier: NCT03388606|
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : June 24, 2022
Almost 20% of Americans have depression. It is a leading cause of disability because it is chronic and it starts early. The highest incidence is among adolescents and young adults. But researchers don t know much about why some people become depressed whilst others don t. One possibility is that the way people process rewarding stimuli could be related to their risk for depression.
To characterize and treat depression in youth by focusing on reward processing.
People ages 11 17 with major depressive disorder or subthreshold depression
Healthy volunteers ages 11 17
Participants will be screened with interviews and questionnaires. They will have memory, thinking, and concentration tests. They may have a urine pregnancy test or have photos or videos taken.
At the initial visit, participants will:
Perform tasks and be interviewed
Have functional magnetic resonance imaging (MRI) scans. For this, participants will lie in a metal cylinder in a magnetic field. They will do study tasks while looking at a screen in the scanner.
Look at pictures of stimuli that signal win (rewards) or loss and get money for making certain choices.
Have brain and eye activity monitored
Do tasks in a virtual reality environment
Wear an activity monitor
Choose to have blood taken for research studies
Perform tasks while in magneto-encephalography a machine that uses sensitive magnetic sensors to measure the brain s electric activity
Participants will get phone prompts at home to ask about their mood.
Participants will have several follow-up visits the first year, then 1-2 each year until they are 25. They will repeat some tasks above.
Some participants with depression can elect to receive outpatient treatment at NIH and can receive inpatient treatment at NIH, if they wish. None of the treatments are experimental, that is, all treatments are standard and have an evidence base. Patients will have more visits before and after they have treatment. They will do some of the tests above plus drug testing. Participants who are in treatment and their parents will talk with a Senior Attending physician, a nurse, social worker, or psychologist. Those in outpatient treatment will have practice work between visits. Those who are inpatients will have practice work during their inpatient treatment and adjustments to medication can be made.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||4100 participants|
|Official Title:||Characterization and Treatment of Adolescent Depression|
|Actual Study Start Date :||December 28, 2017|
|Estimated Primary Completion Date :||July 1, 2025|
|Estimated Study Completion Date :||July 1, 2025|
Adolescents with Major Depression
Adolescents with a current or past history of meeting full critieria for major depressive disorder
Adolescents with sub-threshold Major Depression
Adolescents with no past or current history of major depression who meet criteria at initialenrollment of sub-threshold major depression as defined in the protocol
Health volunteer adolescents
Adolescents with no history of significant psychiatric or medical disorders (as defined in the protocol) currently or in the past.
- Mood and Feelings Questionnaire [ Time Frame: ongoing ]changes in MFQ scores over time
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): NCT03388606
|Contact: Daniel S Pine, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Daniel S Pine, M.D.||National Institute of Mental Health (NIMH)|