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 : September 18, 2020
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Background:
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.
Objective:
To characterize and treat depression in youth by focusing on reward processing.
Eligibility:
People ages 11 17 with major depressive disorder or subthreshold depression
Healthy volunteers ages 11 17
Design:
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 |
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Depression |

Study Type : | Observational |
Estimated Enrollment : | 4100 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
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 |

Group/Cohort |
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Adolescents with Major Depression
Adolescents with a current or past history of meeting full critieria for major depressive disorder
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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
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Health volunteer adolescents
Adolescents with no history of significant psychiatric or medical disorders (as defined in the protocol) currently or in the past.
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- Mood and Feelings Questionnaire [ Time Frame: Ongoing ]changes in MFQ scores over time

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Ages Eligible for Study: | 11 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
- Youths who meet DSM 5 criteria for Major Depressive Disorder (Group 1)
Inclusion criteria for Youth with MDD (all must be met):
- Ages 11-17 at the time of enrollment in Characterization;
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Current diagnosis of DSM-5 Major Depressive Disorder (within the last six months from assessment) which are:
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Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.
- Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, "down in the dumps,"or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.)
- Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing.
- Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day.
- Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day
- Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day
- Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual).
- Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings).
- Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties).
- Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide
- Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning.
- The episode is not attributable to the physiological effects of a substance or to another medical condition.
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Added criteria for Children with MDD entering inpatient treatment. In addition to criteria above, the youth:
- Is failing his/her treatment as defined as a current CGAS score less than or equal to 60
- If the child has a psychiatrist, the child s psychiatrist or treater agrees that the child s response to his/her current treatment makes it clinically appropriate to change the child s current treatment
- On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal
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Added criteria for Children with MDD entering outpatient treatment. In addition to criteria in above, the youth:
---Meets criteria for on-going MDD
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Youths who meet modified DSM criteria for Subthreshold Depression (Group 2)
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Inclusion criteria for subthreshold depressive disorder are:
- Ages 11-17 at the time of enrollment in Characterization;
- An episode of depressed mood or loss of interest or pleasure lasting at least 1 week plus
- At least two of the seven other DSM-5-associated symptoms for major depression
- Occurring in the last six months.
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INCLUSION FOR HEALTHY VOLUNTEERS:
Adolescent Healthy Volunteers (Group 3a)
- Youth 11 to 17 years of age at time of enrollment in Characterization
- The adolescent must be competent to assent; parents must be able comprehend and provide permission for their child (consent).
- Participants will be willing to participate in NIMH IRB approved research protocols. Minors will be asked to sign assent forms and their parents will sign the consent form.
- Participants will be willing to undergo an evaluation which may include a psychiatric interview, review of medical history (including Tanner staging for minors), and pregnancy testing.
- Speaks English
- Have an identified primary care clinician
Adult Healthy Volunteers (Group 3b)
- Adults 18 to 30 years of age at time of enrollment in Characterization
- Subjects must be competent to consent.
- Participants will be willing to participate in NIMH IRB approved research protocols.
- Participants will be willing to undergo an evaluation, which may include a psychiatric interview, review of medical history, and pregnancy testing (for females).
- Speaks English.
- Has an identified primary care clinician.
INCLUSION CRITERIA FOR PARENTS OF ENROLLED YOUTH (Group 4):
- Are the biological parent or legal guardian of an enrolled adolescent (who is a healthy volunteer, has s-MDD, or has MDD) participant
- Those of all ages are eligible if they are a parent of a currently enrolled participant
EXCLUSION CRITERIA: (All patients)
-Exclusion Criteria for MDD patients (Group 1)
- Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, Anorexia Nervosa or other severe Eating Disorder.
- Intellectual disability (clinically identified or IQ less than 70)
- For subjects with major depression or sub-threshold major depressive episode: Symptoms of depression are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition by self and parent report.
- Currently pregnant or lactating by self and parent report and urine pregnancy test.
- Meets DSM-5 criteria for alcohol or substance use disorder (excluding tobacco and nicotine use) within the last three months. This is determined solely by clinical interview of child and parent (e.g. KSADS).
- Current active suicidal ideation (i.e., presence of intent for engaging in suicidal behaviors).
Youths with passive suicidal ideation and/or past active suicidal ideation are still eligible.
- Participants with repeated self-harm occurring in the context of inter-personal conflict.
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NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.
-Exclusion criteria for youths meeting modified DSM criteria for Subthreshold Depression (Group 2):
- Intellectual disability (clinically identified or IQ less than 70).
- Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.
- Past or current diagnosis of a manic or hypomanic episode, major depression), schizophrenia, schizophreniform disorder, schizoaffective illness, Tourette Disorder, or Autism Spectrum Disorder, Anorexia Nervosa or other severe Eating Disorder.
- Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report.
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NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.
-Healthy volunteer youths and/adults exclusion criteria:
- Intellectual disability (clinically identified or IQ less than 70).
- Any serious medical condition (such as epilepsy, heart disease requiring medication) by self and parent report.
- Past or current diagnosis of any mood disorder (manic or hypomanic episode, major depression), anxiety disorder (except specific phobia), Obsessive Compulsive Disorder (OCD), Post-Traumatic Stress Disorders (PTSD), Conduct Disorder, schizophrenia, schizophreniform disorder, schizoaffective illness, Tourette Disorder, or Autism Spectrum Disorder.
- Meets criteria for subthreshold depression (as defined above)
- Meets DSM-5 criteria for alcohol or substance abuse within the last three months by self and parent report; for adults, past history of substance dependency or substance abuse within the last three months by self-report.
- NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.
Parents of enrolled participants exclusion criteria:
- Parents who are unable to understand or read English well enough to complete the study interview and tests.
- Parents who are a current NIMH employee, or staff member, or a family member of an NIMH employee. NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.

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: Argyris Stringaris, M.D. | (301) 443-8019 | argyris.stringaris@nih.gov |
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 prpl@cc.nih.gov |
Principal Investigator: | Argyris Stringaris, M.D. | National Institute of Mental Health (NIMH) |
Responsible Party: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT03388606 |
Other Study ID Numbers: |
180037 18-M-0037 |
First Posted: | January 3, 2018 Key Record Dates |
Last Update Posted: | September 18, 2020 |
Last Verified: | September 16, 2020 |
Cognitive Behavior Therapy Major Depressive Disorder Mood Disorder Biomarkers Mechanism |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |