Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation

Обзор

Evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD).

Подробное описание

The overall goal of this study is to evaluate the feasibility, safety, and preliminary efficacy of deep Transcranial Magnetic Stimulation (dTMS) as an adjunctive treatment for adolescents hospitalized with major depressive disorder (MDD). Our central hypotheses are that dTMS H7 targeting the dorsomedial prefrontal and cingulate cortices, delivered via the Brainsway H7-Coil™, will be safe, well tolerated, and lead to improved depressive symptoms, reduced suicide risk, and lower readmission rates compared to sham treatment. Investigators propose a double-blind, sham-controlled randomized clinical trial enrolling 14- to 18-year-old inpatients with MDD with or without obsessive compulsive disorder (OCD). Participants (n=60) will be randomized to receive either active or sham TMS during hospitalization, with follow-up assessments continuing for 12 months post-discharge. Outcomes will include safety, tolerability, treatment adherence, depressive symptom change, suicidal ideation, and time to psychiatric readmission. This study will provide foundational data to support the clinical integration of TMS into inpatient care for adolescents with treatment-resistant depression.

Вмешательства

• Устройство Transcranial Magnetic Stimulation
  The Brainsway Deep TMS System with the FDA-cleared H7 Coil will be used to deliver all accelerated theta burst stimulation (aTBS) sessions. The H7 Coil is designed to target deeper and broader brain regions, including the prefrontal and anterior cingulate cortices, and has FDA 510(k) clearance for treatment of OCD and MDD in adults. Stimulation will follow a standardized accelerated theta burst protocol: triplet 50 Hz bursts delivered every 200 ms (5 Hz), in 2-second trains with 8 seconds off, a
• Устройство Transcranial Magnetic Stimulation Sham
  Investigators will use a robust sham technique that is manufacturer-designed to mimic the auditory and tactile sensations of active TMS without delivering effective magnetic stimulation to the brain. The Brainsway Sham H7-CoilTM will be utilized for treatment delivery. The H-7 coil already has a built-in sham system that can operate as a placebo. Only the TMS operators will have access to intervention assignments, the rest of the study team will not have access to assignments to maintain the bli

Первичные конечные точки

• Tolerability and Safety [Срок оценки: Completed before and immediately after the intervention]

Вторичные конечные точки (3)

• Hospitalization [Срок оценки: Completed monthly for the first 6 months, 9th and 12th month follow up]
• Depression Symptoms [Срок оценки: Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up]
• Suicide Risk [Срок оценки: Completed at screening, same day after the intervention, monthly for 6 months, then at 9th and 12th month follow up]

Критерии участия

Критерии включения

• Fluent in English and able to volunteer in the informed consent process and provide spontaneous narrative description of key elements, risks, and benefits of the study.
• Aged 14 years to 18 years, inclusive.
• Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview.
• Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score > 20.
• Participants are not required to discontinue current interventions

Критерии исключения

• Participation in an investigational drug trial within the past three months.
• Contraindications to Transcranial Magnetic Stimulation including, but not limited to, a history of epilepsy, the presence of metallic foreign bodies, or implanted medical devices (e.g. ventriculoperitoneal shunt, pacemaker, medical pump).
• Actively psychotic (i.e. disorganized, delusional, paranoid, or having hallucinations)
• Actively suicidal (have a suicidal plan and intent and is on 1:1 close observation)
• For female subjects of childbearing potential, a positive urine pregnancy test.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cincinnati Childrens Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT07217444 · 2025-0385

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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