Characterization and Treatment of Adolescent Depression
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Mental Health (NIMH)
- Study ID
- NCT03388606
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - 25 Years
- Healthy Volunteers
- Accepted
Interventions
- Growth Mindset — BEHAVIORAL30 Minute interactive video
Study Details
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.
Key Dates
- Start date
- Dec 28, 2017
- Status verified
- Apr 2026
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 4,100 participants (estimated)
Arms
- Arm: Adolescents with major depressionAdolescents with a current or past history of meeting full critieria for major depressive disorder
- Arm: Healthy volunteer adolescents/young adultsAdolescents with no history of significant psychiatric or medical disorders (as defined in the protocol) currently or in the past.
- Arm: Parents of adolescent participantsbiological 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
Primary Outcome Measure
Mood and Feelings Questionnaire [ Time Frame: ongoing ]
Central Contacts
- Daniel S Pine, M.D.(301) 594-1318
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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