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Teen depression brain study seeks clues in stress and control

NCT ID NCT04788524

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at how stress and a sense of control affect brain activity in teenage girls with major depression. Researchers will use brain scans and smartphone surveys to understand these connections. The goal is to learn more about depression, not to test a new treatment. About 80 girls aged 14-18 will take part.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Started

Apr 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

14 to 18 years

Sex

Female participants only

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: * Inclusion Criteria: All Participants 1. Females of all ethnic origins See Section: Inclusion of Women and Minorities); 2. Ages 14-18 (See Section: Inclusion of Children); 3. Written informed assent/consent from adolescent and parent/guardian (if under age 18); 4. English as a first language or English fluency; 5. Right handed111; 6. Personal cell-phone (for Ecological Momentary Assessment \[EMA\]) 7 All participants will be in the follicular phase of their menstrual cycle when completing the functional magnetic resonance imaging (fMRI) study session Inclusion Criteria: MDD Sample 1. Meet Diagnostic Statistical Manual-5th edition (DSM-5) diagnostic criteria for major depressive disorder (as diagnosed with the KSADS) 2. Absence of any psychotropic medications for at least 2 weeks (6 weeks for fluoxetine; 6 months for neuroleptics; 2 weeks for benzodiazepines; 2 weeks for any other antidepressants); Inclusion Criteria: Healthy Control (HC) Sample 1. No history or current diagnosis of any DSM-5 psychiatric or substance/alcohol-related disorder (as diagnosed with the KSADS) 2. No first-degree relatives with a history of depression, bipolar disorder, or psychosis Exclusion Criteria: * Exclusion Criteria: All Participants 1. History of head trauma with loss of consciousness; 2. History of seizure disorder; 3. Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; 4. History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine); 5. History of use of dopaminergic drugs (including methylphenidate); 6. Use of hormonal replacement therapy, anabolic steroids, or hormonal contraception; 7. Clinical or laboratory evidence of hypothyroidism; 8. Systemic medical or neurological illness that could impact fMRI measures of cerebral blood flow; 9. Failure to meet standard exclusion criteria for fMRI scanning (e.g., claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other metal objects in the body); 10. Pregnancy 11. Testing positive on a drug test on the day of the scan which testis for stimulants, marijuana, barbiturates, benzodiazepine, buprenorphine, 3,4-Methyl enedioxy methamphetamine (MDMA), methadone, opiates, oxycodone, phencyclidine; 12. History of electroconvulsive therapy 13. Participants with suicidal ideation where study participation is deemed unsafe by the study clinician; Additional Exclusion Criteria: Major Depressive Disorder (MDD) Sample 1\. Major depressive disorder diagnosis secondary to another disorder (selected comorbid anxiety disorders such as generalized anxiety disorder, specific phobia, and social anxiety disorders are allowed if they are secondary to MDD)

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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

  • McLean Hospital

    RECRUITING

    Belmont, Massachusetts, 02478, United States

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