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.
Objective
Depression has a prevalence of 19% in the US population and close to 350 million people suffer from the disorder worldwide. The chronic course of depression and its early onset-a maximal incidence in adolescence and young adulthood contribute to it being a leading cause of disability worldwide. Yet, compared to many other medical conditions, we know little about the mechanisms underlying depression. In recent years, reward processing has been proposed to underlie several key behavioral and neural aberrations observed in depression. This has led to the promise that targeting reward processing may lead to much needed breakthroughs in the field. In this protocol we seek to characterize and treat depression in youth by integrating methodological and conceptual approaches that specifically focus on reward processing. Patients and their families can elect to participate in standard outpatient or inpatient clinical care in this protocol. Our objective is to answer four key questions:
Studies from our own group demonstrate that stress in early life has an impact on how rewards and punishers are processed in the brain several years later. Similarly, there is good evidence for the acute effects of stress on reward processing, as indicated in our recent metanalysis. And, of course, there is ample evidence for the role on how stressful events worsen symptoms of depression.
The emergence of the COVID-19 pandemic presents an unprecedented challenge for the world s physical health but it also has had a profound impact on people s psychological wellbeing. The COVID-19 pandemic presents an opportunity for us, using longitudinal methods, to learn more about how humans respond to such environmental influences.
While the most extreme measures to promote public health have been rolled back, the ongoing effects of the COVID-19 pandemic remain important and have received limited attention. Thus, we will continue to use in-person and on-line methods to learn about the aftermath of the pandemic and the stress of returning to school and workplaces.
We also wish to explore more deeply the role of family environment on stress in teens with major depression. There is a substantial literature on the role of family environment in moderating or exacerbating stress in teens, and measuresand methods to assess this would be important to understand its role in teen depression.
Study population
We will study three populations: (1) Healthy volunteer children and adults (HVs; n=600); (2) Participants with Major Depressive Disorder (MDD; n=500); (3) parents (biological or legal guardians) of children with MDD or HVs who are enrolled in this protocol (N=800 total as 400/200/200 respectively). Study participants will be aged 11-17 years at initial enrollment in Characterization; this is a longitudinal study and participants who turn 18 may continue in it for up to two years. Previously we enrolled 4 cohorts. Youths with Subthreshold Depression (s-MDD) (n=200 were to be enrolled; we have enrolled n=8 over the life of the protocol and no subjects with s-MDD have been enrolled after Dec 2021)
Design
This is a Characterization study that, as of 2022, includes longitudinal observation of two adolescent cohorts. HV and MDD subjects will take part in a longitudinal, observational study that involves clinical assessment, computer tasks, fMRI and MEG scanning and continue to return for up to two years. A sample of young adult HVs (18-30 years old) will also be enrolled as a comparison cohort. Those previously enrolled as subthreshold MDD (s-MDD) will be followed for up to two years (from their initial enrollment); with Amendment J, we ceased enrolling this population; no new participants with s-MDD have been enrolled since Dec, 2021.
Adolescent patients who still suffer from MDD will be offered outpatient clinical care in the form of open-label Interpersonal Psychotherapy for Adolescents (IPT-A, Mufson et al up to 26 weeks) or Cognitive Behavioral Therapy (CBT; up to 26 weeks). The patient and families can choose which form of psychotherapy they prefer. Those who are on medication when they enroll will be able to continue their medications. Those who do not improve with psychotherapy, will be offered medication plus psychotherapy for up to 12 weeks. Furthermore, for those who are on medication when they enroll and do not improve when psychotherapy is added, we will offer to change the dose or provide a trial of a different drug than the one they have been receiving. During and following outpatient clinical care, participants with MDD will continue in Characterization. Upon completion of clinical care, patients will return to care in the community or be offered participation in other IRP depression protocols, as appropriate.
Outcome measures
For Objective 1
Primary Outcomes
fMRI: Monetary incentive delay task
Magnetoencephalography: Monetary incentive delay task
Automated Affect encoding: variables obtained through machine learning analysis
For Objective 2
Primary outcomes:
fMRI: Monetary Incentive Delay Task
Questionnaires: MFQ, ARI, SCARED
For Objective 3
Primary outcomes:
Questionnaires: PCSC, SCSC, MFQ
Imaging (fMRI): Activity in prefrontal cortex and striatum in response to controllable setback cues in the Persistence after Setbacks task
For Objective 4
Primary outcomes:
Questionnaires: MFQ, ARI, SCARED, COVID-19 Questionnaire, CRISIS Questionnaire
Secondary outcomes:
Questionnaires: Family-function measures (FAD, FBS, and FRFC-P) quality of life measure (PQ-LES-Q)
Behavioral task: Five Minute Speech Sample, Parent-Child Discussion Task, SMT, Mood Induction, Etch-a-Sketch task, Parent-Child Discussion Task (PCDT)
Condition | Depression |
---|---|
Treatment | Growth Mindset, Comparison Session |
Clinical Study Identifier | NCT03388606 |
Sponsor | National Institute of Mental Health (NIMH) |
Last Modified on | 7 October 2022 |
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