Characterization and Treatment of Adolescent Depression

NCT03388606 | Recruiting

• 2 other identifiers: 18003718-M-0037
• Study Type: observational
• Target: 4,100
• Locations: 1 country
• Sites: 1

Brief Summary

This research study seeks to find causes and treatments of depression in teenagers. The study goals are to increase our knowledge of treatments for depression and understand how the brain changes when teenagers have depression. The study will also compare teenagers with depression to those without mental health diagnoses. This outpatient study is recruiting participants ages 11-17 who are depressed. They must have a pediatrician or other medical provider, be medically healthy, and able to perform research tasks. They may not currently be hospitalized, psychotic or actively suicidal. Teenagers with depression are eligible even if they are taking medication. The study begins with an evaluation that includes clinical assessment, interviews, and questionnaires.

• Visits may include paper-and-pencil and computer tests of mood, memory, and thinking; specialized computer games; and structural and brain imaging. If eligible, study participants may return several times a year for up to two years. This part of the study does not involve treatment.
• Participants may be eligible for outpatient treatment for up to 25 weeks. This includes evidenced-based "talk" therapy. Participants may choose either Interpersonal Psychotherapy for Adolescents (IPT-A) or Cognitive Behavioral Therapy (CBT). If indicated, participants may opt to receive standard medication treatments along with psychotherapy. Research includes computer tasks and brain imaging. All clinical evaluations, research tasks and visits are free of cost. Participants are compensated for research activities. Parents and teenager must agree to the teenager s participation in research. The study is conducted at the NIH in Bethesda, Maryland and enrolls participants from the Washington DC Metro region within 50 miles of NIH. Transportation expenses are reimbursed by NIMH.

Conditions

Depression

Keywords

Cognitive Behavior Therapy; Mood Disorder; Biomarkers; Mechanism; Major Depressive Disorder (MDD); Natural History

Outcome Measures

Primary Outcomes (1)

• Mood and Feelings Questionnaire

  changes in MFQ scores over time

  ongoing

Study Arms (3)

Adolescents with major depression

Adolescents with a current or past history of meeting full critieria for major depressive disorder

Behavioral: Growth Mindset

Healthy volunteer adolescents/young adults

Adolescents with no history of significant psychiatric or medical disorders (as defined in the protocol) currently or in the past.

Parents of adolescent participants

biological parent or legal guardian of an enrolled adolescent (who is a healthy volunteer, has s MDD \[subthreshold depression\], or has MDD \[Major Depressive Disorder\]) participant

Interventions

Growth Mindset BEHAVIORAL

30 Minute interactive video

Adolescents with major depression

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A clinical population of depressed adolescents age 11-17 (inclusive)@@@

You may qualify if:

• Youths who meet DSM 5 criteria for Major Depressive Disorder (Group 1)
• Ages 11-17 at the time of enrollment in Characterization;
• Current diagnosis of DSM-5 Major Depressive Disorder (within the last six months from assessment) which are:
• 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.

You may not qualify if:

• Meets criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, current Anorexia Nervosa or other severe Eating Disorder.
• Intellectual disability (clinically identified or IQ \< 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.
• 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.
• Intellectual disability (clinically identified or IQ \< 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.
• NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy.
• Intellectual disability (clinically identified or IQ \< 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Sadeghi N, Fors PQ, Eisner L, Taigman J, Qi K, Gorham LS, Camp CC, O'Callaghan G, Rodriguez D, McGuire J, Garth EM, Engel C, Davis M, Towbin KE, Stringaris A, Nielson DM. Mood and Behaviors of Adolescents With Depression in a Longitudinal Study Before and During the COVID-19 Pandemic. J Am Acad Child Adolesc Psychiatry. 2022 Nov;61(11):1341-1350. doi: 10.1016/j.jaac.2022.04.004. Epub 2022 Apr 19.

  PMID: 35452785 DERIVED

• Gorham LS, Sadeghi N, Eisner L, Taigman J, Haynes K, Qi K, Camp CC, Fors P, Rodriguez D, McGuire J, Garth E, Engel C, Davis M, Towbin K, Stringaris A, Nielson DM. Clinical utility of family history of depression for prognosis of adolescent depression severity and duration assessed with predictive modeling. J Child Psychol Psychiatry. 2022 Aug;63(8):939-947. doi: 10.1111/jcpp.13547. Epub 2021 Nov 30.

  PMID: 34847615 DERIVED

• Keren H, Zheng C, Jangraw DC, Chang K, Vitale A, Rutledge RB, Pereira F, Nielson DM, Stringaris A. The temporal representation of experience in subjective mood. Elife. 2021 Jun 15;10:e62051. doi: 10.7554/eLife.62051.

  PMID: 34128464 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Depression; Mood Disorders; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Depressive Disorder

Study Officials

• Daniel S Pine, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel S Pine, M.D.

CONTACT

(301) 594-1318; daniel.pine@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2017
• First Posted: January 3, 2018
• Study Start: December 28, 2017
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)