Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation
Recruiting · NCT07217444 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →Interventions studied
Transcranial Magnetic StimulationTranscranial Magnetic Stimulation Sham
What this trial is 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).
Who can take part
Age range
14 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio, United States