Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder (NCT05652465) | Clinical Trial Compass
WithdrawnPhase 2
Transcranial Magnetic Stimulation for Youth With Treatment-Resistant Major Depressive Disorder
Stopped: Not able to enroll subjects for this study.
United States0Started 2026-04-25
Plain-language summary
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.
Who can participate
Age range13 Years – 17 Years
SexALL
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Inclusion criteria
✓. Ages 13-17 at the time of enrollment
✓. Provision of signed and dated informed consent/assent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Is considered in good health and able to fulfill all study requirements in a manner that will not adversely impact the integrity of the data, as determined by the PI after review, as applicable, of a detailed screening assessment consisting of psychiatric and medical history, mental status, physical examinations, and laboratory assessments. In some circumstances it may also be highly desirable to review medical records from healthcare providers for the 2 years prior to study enrollment, from hospitals, psychiatric facilities, and pharmacy records for the year prior to study enrollment.
✓. Youths meet DSM 5TR criteria for Major Depressive Disorder (MDD), with a current, ongoing episode of MDD being present.
✓. To enter the trial, patients must meet criteria for treatment resistance, defined in the prior study of Croarkin and coworkers as the failure to respond to adequate trials or failure to tolerate trials of at least two selective serotonin reuptake inhibitors and a trial of either cognitive behavioral therapy or Interpersonal Psychotherapy for Adolescents (IPT-A). However, to receive TMS, patients must meet criteria for a stricter definition of treatment resistance. They must fail to respond to three interventions; only subjects who received and failed all three interventions will be invited to enroll into the TMS study. This will be defined as at least 20 mg of fluoxetine, 20 mg of citalopram (or 10 mg escitalopram), and 150 mg of sertraline. One of these interventions will involve psychotherapy with either Interpersonal Psychotherapy for Adolescents (IPT-A) or cognitive behavioral therapy (CBT) for at least 12 weeks. Of note, these treatments either can be delivered in the community, as determined based on medical history, or they can be delivered as part of protocol 18-M-0037.
✓. Subject agrees to a Safety/Suicide Risk Management Protocol, which is intended to reduce the reduce the risk of suicide during study participation.
✓. Subject is currently under the care of a licensed prescriber and agrees to return to that provider upon completion of the study. During study participation, patients may continue to meet with their providers in the community, if they wish.
Exclusion criteria
✕. 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