Deep TMS for adolescents hospitalized with depression
Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
This trial will try deep transcranial magnetic stimulation (dTMS) as an add-on to usual care for 14–18-year-olds hospitalized with major depressive disorder to see if it reduces depressive symptoms, suicidal thoughts, and readmissions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 14 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT07217444 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, sham-controlled randomized trial enrolling 60 inpatients aged 14–18 with moderate-to-severe major depressive disorder. Participants will be randomized to active or sham deep TMS delivered with the Brainsway H7 coil targeting dorsomedial prefrontal and cingulate cortices during hospitalization. The study will track safety, tolerability, adherence, changes in depressive symptoms and suicidal ideation, and time to psychiatric readmission. Follow-up assessments will continue for 12 months post-discharge to capture longer-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are 14–18-year-old inpatients with moderate-to-severe MDD (Hamilton Depression Rating Scale >20) who can participate in informed consent/assent in English and are not actively psychotic or otherwise contraindicated for TMS.
Not a fit: Patients with TMS contraindications (for example a history of epilepsy or certain metallic implants/medical devices), those who are actively psychotic or currently have a suicidal plan with intent requiring one-to-one care, or those outside the 14–18 age range are unlikely to be eligible or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, dTMS could provide a noninvasive adjunct treatment that reduces depressive symptoms and suicidal risk and lowers psychiatric readmissions for hospitalized adolescents.
How similar studies have performed: Repetitive TMS has proven efficacy for adult depression and early work supports safety in adolescents, but dTMS targeted to the dorsomedial prefrontal cortex in hospitalized adolescents remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Rana Elmaghraby, MD — Cincinnati Childrens Hospital Medical Center
- Study coordinator: Ashley Krafft, Masters
- Email: ashley.krafft@cchmc.org
- Phone: 5138038644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.