Anxiety & Depression Association of America

Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation

Purpose

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).

Conditions

Major Depressive Disorder (MDD)
Suicidal Ideation
Hospitalization in Children

Eligibility

Eligible Ages: Between 14 Years and 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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. 2. Aged 14 years to 18 years, inclusive. 3. Diagnosis of MDD based on psychologist diagnosis and DSM-5-checklist based interview. 4. Symptoms of moderate to severe depression according to Hamilton Depression Rating Scale Score > 20. 5. Participants are not required to discontinue current interventions

Exclusion Criteria

Participation in an investigational drug trial within the past three months. 2. 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). 3. Actively psychotic (i.e. disorganized, delusional, paranoid, or having hallucinations) 4. Actively suicidal (have a suicidal plan and intent and is on 1:1 close observation) 5. For female subjects of childbearing potential, a positive urine pregnancy test.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It's a randomized sham-controlled trial with deep Transcranial Magnetic Stimulation (dTMS) treatment and sham controlled group
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Active dTMS Treatment	Participants will receive active dTMS 5 sessions per day for 5 days	Device: 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, at 90% RMT, totaling 600 pulses per session. Participants will receive five sessions per day over five days with 30-minute breaks between the third and fourth sessions and exceeding or preceding these breaks will not be a protocol deviation. The sham coil mimics sensory experience without delivering stimulation.
Sham Comparator Sham controlled	Sham dTMS 5 sessions per day for 5 days. If participants in the sham group do not show a significant treatment response by the 12th month follow-up -reduction in depression symptoms from screening - they will then become eligible for and offered active, open-label treatment.	Device: 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 blinded status of participants, caregivers, and raters.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Children's Hospital Medical Center, Cincinnati

Study Contact

Mohana Priya Santhan Ramesh Kumar Padma, Masters
5136364433
priya.ramesh@cchmc.org

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.