Actively Recruiting

Age: 11Years - 25Years
All Genders
Healthy Volunteers
NCT03388606

Characterization and Treatment of Adolescent Depression

Led by National Institute of Mental Health (NIMH) · Updated on 2026-04-29

4100

Participants Needed

1

Research Sites

443 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Characterization and Treatment of Adolescent Depression

Who Can Participate

Age: 11Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Youths aged 11 to 17 years at enrollment
  • Current diagnosis of DSM-5 Major Depressive Disorder within the last six months
  • Five or more depressive symptoms present during the same two-week period, including depressed mood or loss of interest
  • Symptoms cause significant distress or impairment in social, academic, or other important areas
  • Episode is not due to substance effects or another medical condition
  • Adolescent healthy volunteers aged 11 to 17 years able to assent with parent consent
  • Adults 18 to 30 years old healthy volunteers competent to consent
  • Parents or legal guardians of enrolled adolescents (healthy or with MDD)
Not Eligible

You will not qualify if you...

  • Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, or severe Autism Spectrum Disorder
  • Current Anorexia Nervosa or other severe eating disorder
  • Intellectual disability or IQ below 70
  • Depression symptoms caused by drug abuse or medical/neurological condition
  • Alcohol or substance use disorder within the last three months
  • Current active suicidal ideation with intent
  • Repeated self-harm related to interpersonal conflict
  • Past or current diagnosis of manic or hypomanic episodes, schizophrenia, Tourette Disorder, or Autism Spectrum Disorder for subthreshold depression group
  • Serious medical conditions such as epilepsy or heart disease requiring medication
  • Healthy volunteers with past or current mood, anxiety (except specific phobia), OCD, PTSD, conduct disorder, schizophrenia, or substance abuse within three months
  • Parents unable to understand or read English well enough to complete study tasks
  • NIMH staff and immediate family members

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

D

Daniel S Pine, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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