Depression and Anxiety Trial, Recruiting NCT03388606 Sponsor: National Institute of Mental Health (NIMH) Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT03388606
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Young people with depression (ages 11–17):

  • You are between 11 and 17 years old
  • You have been diagnosed with Major Depressive Disorder (clinical depression) within the last 6 months
  • You have had 5 or more of the following symptoms during the same 2-week period, including at least one of the first two listed: feeling sad, down, or irritable most of the day nearly every day; losing interest or enjoyment in activities you used to like; significant unexplained weight change or change in appetite; trouble sleeping or sleeping too much; feeling restless or unusually slowed down; feeling very tired or having no energy; feeling worthless or very guilty; having trouble thinking, concentrating, or making decisions; having recurring thoughts of death or suicide
  • These symptoms cause real problems in your daily life, school, or relationships
  • These symptoms are not caused by drugs, alcohol, or another medical condition

Healthy volunteer teenagers (ages 11–17):

  • You are between 11 and 17 years old and do not have a mental health condition
  • You are able to agree to take part, and your parent or guardian is able to give permission
  • You are willing to take part in research approved by the NIMH review board
  • You are willing to go through an evaluation that may include a mental health interview, medical history review, and possibly a pregnancy test
  • You speak English
  • You have a regular doctor (primary care clinician)

Healthy volunteer adults (ages 18–30):

  • You are between 18 and 30 years old and do not have a mental health condition
  • You are able to give your own consent to take part
  • You are willing to take part in research approved by the NIMH review board
  • You are willing to go through an evaluation that may include a mental health interview, medical history review, and possibly a pregnancy test (for females)
  • You speak English
  • You have a regular doctor (primary care clinician)

Parents or legal guardians of enrolled young participants:

  • You are the biological parent or legal guardian of a young person already enrolled in this study
  • Parents of any age may be eligible

Who may not be able to join:

Young people with depression:

  • You have been diagnosed with schizophrenia, bipolar disorder, more than mild autism spectrum disorder, or a severe eating disorder such as anorexia nervosa
  • You have an intellectual disability, or your IQ has been measured below 70
  • Your depression symptoms are caused directly by drug or alcohol use, or by another medical or neurological condition
  • You have had an alcohol or substance use problem (not including tobacco or nicotine) in the last 3 months
  • You currently have active thoughts of suicide with the intention to act on them (note: passive thoughts about death or past suicidal thoughts do not automatically disqualify you — confirm with trial site)
  • You repeatedly hurt yourself in connection with personal conflicts

Healthy volunteer teenagers and adults:

  • You have an intellectual disability, or your IQ has been measured below 70
  • You have a serious medical condition such as epilepsy or heart disease requiring medication
  • You have ever been diagnosed with a mood disorder, anxiety disorder (except a specific phobia), OCD, PTSD, conduct disorder, schizophrenia, bipolar disorder, Tourette's disorder, or autism spectrum disorder
  • You have had an alcohol or substance use problem in the last 3 months; for adults, this also includes a past history of substance dependency

Parents or legal guardians:

  • You are not able to read or understand English well enough to complete the study interviews and tests

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
28 December 2017
Est. completion
1 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mood and Feelings Questionnaire

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov