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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    60
  • sponsor
    Children's Hospital Medical Center, Cincinnati
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Updated on 17 October 2025
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Summary

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).

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.

Details
Condition Major Depressive Disorder (MDD), Suicidal Ideation, Hospitalization in Children
Age 14years - 18years
Clinical Study IdentifierNCT07217444
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on17 October 2025

Eligibility

 Yes No Not Sure

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
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

Exclusion Criteria

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
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