Status:
RECRUITING
Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Major Depressive Disorder (MDD)
Suicidal Ideation
Eligibility:
All Genders
14-18 years
Phase:
NA
Brief 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)...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07217444
Start Date
October 15 2025
End Date
December 30 2026
Last Update
October 16 2025
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45224