Characterization and Treatment of Adolescent Depression (NCT03388606) | Clinical Trial Compass
RecruitingNot Applicable
Characterization and Treatment of Adolescent Depression
United States4,100 participantsStarted 2017-12-28
Plain-language 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.
Who can participate
Age range
11 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
Exclusion Criteria for MDD patients (Group 1)
Exclusion criteria for youths meeting modified DSM criteria for Subthreshold Depression (Group 2) (this cohort is historical only; previously n=200 to be enrolled; ceased enrolling this population with Amendment J (2022); none enrolled after Dec 2021):
Healthy volunteer youths and adults exclusion criteria:
-Parents who are unable to understand or read English well enough to complete the study interview and tests.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as Phase NA — what does that mean for what's already known about the safety and effectiveness of the approaches being tested here, and how does that affect whether it might be right for my teen?
2The primary outcome being measured is something called the Mood and Feelings Questionnaire — can you explain what that tool actually captures, and what it would mean if my teen's scores improved or didn't improve during the study?
3Since the trial focuses on 'characterization' of adolescent depression as well as treatment, does that mean my teen would go through detailed assessments or evaluations beyond just receiving care, and how much time and effort would that involve for our family?
4Given that this study is still actively recruiting, are there standard depression treatments available right now that we should consider first, or would participating in this trial be a reasonable alternative at this stage of my teen's diagnosis?
5What types of adolescents is this trial designed for — for example, does it target a specific severity of depression, age range, or situation — and is my teen's current presentation a good fit to even have this conversation with the research team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.