Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation (IMPACT-D)

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Hospitalization in Children; Suicidal Ideation; Major Depressive Disorder (MDD)

Treatments: Device: Transcranial Magnetic Stimulation Sham; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07217444

2025-0385

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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

1. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Active dTMS Treatment

Active Comparator group

Description:

Participants will receive active dTMS 5 sessions per day for 5 days

Treatment:

Device: Transcranial Magnetic Stimulation

Sham controlled

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Magnetic Stimulation Sham