Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder

Withdrawn before enrolling · Phase 2

Conditions studied: Major Depressive Disorder

In brief

Background: Major depressive disorder (MDD) is one of the most impairing medical conditions in the world. Medication and some kinds of talk therapy are standard treatments for teens with MDD, but these do not work well for everyone. Transcranial magnetic stimulation (TMS) has been approved to treat MDD in adults. TMS might help adolescents, too. Objective: To test TMS combined with cognitive behavioral therapy (CBT) in teens with MDD. Eligibility: People aged 13 to 17 years with MDD that has not responded to treatment. Design: Participants will be screened. They will have a physical exam and psychiatric evaluation. They will have an MRI scan and a test of their heart function. They will enroll in 2 NIH protocols (01-M-0254 and 18-M-0037). For 2 to 6 weeks, participants will have weekly CBT, a kind of talk therapy. They will taper off of their psychiatric medicines. For 2 weeks, participants will come to the clinic every weekday. They will receive 3 or 4 sessions of TMS on each of those days. A wire coil will be held on their scalp. A brief electrical current in the coil creates a magnetic pulse that affects brain activity. They will receive 30 TMS pulses in 10-second bursts; these will be repeated 60 times in each 15-minute session. Participants may hear a click and feel a pulling sensation under the coil. They may feel their muscles twitch. Each day, they will have tests of concentration, thinking, and memory. Some may have a 3rd week of TMS. Participants will remain in the study for 5 more weeks. They will begin taking their medications again.

Key facts

Study ID: NCT05652465
Run by: National Institute of Mental Health (NIMH)
People needed: 0
Starts: 2026-04-25
Expected to finish: 2026-04-25
Last updated by the study team: 2026-04-28

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
Meets diagnostic criteria of DSM-5TR for psychosis, bipolar disorder, more than mild Autism Spectrum Disorder, ongoing severe Eating Disorder, ongoing substance use disorder (excluding nicotine) within the past month
In the opinion of the PI, has a current or past medical or neurological disease, condition, injury, or illness (i.e., hearing loss, increased intracranial pressure, structural brain lesion, or head trauma associated with neurological sequalae, loss of consciousness, or hospitalization) that may: (a) reduce or diminish the subject s ability to fulfill all of the study requirements; or (b) adversely affect the integrity of the data or the results of the study. This includes the need for routine use of any medication (except for contraceptive implants or oral contraceptives) for any reason.
Pregnancy
Personal history of epilepsy, seizure(s), seizure disorder, or answers Yes to any of the nine (9) questions from the epilepsy screening instrument developed by Ottman et al.
Has a history of, or risk factors for (history of syncope/ presyncope related to noxious stimuli, anxiety, micturition, or posture) for neurocardiogenic syncope
Currently receiving medication(s) that may, or is known to, reduce the seizure threshold and which, in the opinion of the PI, poses a clinically significant risk of a TMS-induced seizure that outweighs the potential benefit(s) of study participation.
Lifetime lack of response to an adequate trial of electroconvulsive therapy
Prior treatment with adequate trial of TMS
Vagus nerve stimulator implant or other device implants
Presence of intracranial implants or any other metal object within or near the head; those who have permanent retainers or other dental implants in the mouth that produce artifacts that compromise the integrity of MRI/fMRI data will be excluded from participation in this study.
Intellectual disability (clinically identified or IQ less than 70)
Symptoms of depression are due to physiologic effects of a drug of abuse or to a medical or neurological condition, as determined by the PI, based on history of contemporaneous onset of the symptoms and the associated drug or medical or neurological condition.
Current active suicidal ideation (i.e., presence of intent for engaging in suicidal behaviors with a plan to act on the ideation) as demonstrated by a YES response to questions 4, 5 or 6 on the Columbia-Suicide Severity Rating Scale (Screen Version - Recent). [Note: Youths with passive suicidal ideation and/or past active suicidal ideation are still eligible - Answer Yes to Questions 1, 2 or 3.]
Participants with recent or current history of repeated self-harm or suicide attempts occurring in the context of interpersonal conflict.
NIMH IRP Employees/staff and immediate family members of such staff will be excluded from the study per NIMH policy.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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