Personalized Accelerated TMS for High-Risk Adolescent Depression (PATH-RAD)

University of California (UC) Davis

Status: Enrolling

Conditions: Suicidal Ideation; Major Depressive Disorder (MDD)

Treatments: Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07025720

2227384

Details and patient eligibility

About

The goal of this clinical trial is to learn if a fast-acting brain stimulation treatment called transcranial magnetic stimulation (TMS) can help people with depression and suicidal thoughts. The treatment is non-invasive (does not involve surgery or medications), is given over 5 days, and uses brain imaging (MRI) to guide which part of the brain to target. This study tests whether this treatment is a helpful and practical option for adolescents and young adults who are depressed and have suicidal thoughts.

We want to see if:

1. This treatment is feasible and acceptable to patients
2. It can reduce depression and suicidal thoughts
3. It can lower the chance of going to the hospital
4. It affects daily functioning (school, work, relationships)

All participants will undergo 5-days of TMS treatment and complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.

Enrollment: 25 estimated patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• Able to provide informed consent
• age 15 years or older
• Discharged within the past week from the ED for chief complaint of SI OR recently admitted in urgent health care setting or seen in outpatient clinic for depression-related suicidal ideation
• Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)

Exclusion criteria

• Unable to consent (due to medical condition, psychosis, substance use, etc)
• Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
• Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
• Untreated, active psychosis
• Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
• Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
• Contraindications to receiving TMS and/or MRI as determined by screening questionnaires

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

TMS

Experimental group

Treatment:

Device: TMS