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NIH launches major study to uncover teen Depression's secrets

NCT ID NCT03388606

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 18 times

Summary

This NIH study aims to understand what causes depression in teenagers and how the brain changes with the condition. Researchers will compare depressed teens with healthy ones using interviews, computer tasks, and brain scans. Eligible participants may also receive free talk therapy for up to 25 weeks. The study is recruiting 4,100 teens aged 11-17 from the Washington DC area.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Growth Mindset video and talk therapy (IPT-A or CBT)
What this could lead to
If successful, this could improve understanding of adolescent depression and point toward more effective talk therapies.
What could go wrong
This is an early-stage observational and treatment study, not a large-scale trial. Results may not apply to all teens with depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2017

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

11 to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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; * 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. INCLUSION CRITERIA 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 or has MDD) participant; Parents of those with s-MDD are historical only; none enrolled after Dec 2021. * 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, 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. -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): * 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. -Healthy volunteer youths and adults exclusion criteria: * 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. * 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. Parents of enrolled participants (group 3) exclusion criteria: --Parents who are unable to understand or read English well enough to complete the study interview and tests.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • University of Colorado

    COMPLETED

    Denver, Colorado, 80220-3706, United States

  • University of Southern California

    COMPLETED

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.