Maintenance TMS for Depression

Recruiting in Palo Alto (17 mi)

Overseen ByLinda Carpenter, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Butler Hospital

Stay on your current meds

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants' smart phones. Adaptive algorithm software will monitor each participant's PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy.

Eligibility Criteria

This trial is for individuals with Major Depressive Disorder who've had a positive response to Transcranial Magnetic Stimulation (TMS) therapy. Participants must have a PHQ-9 score under 10, access to a smartphone, and be medically cleared for TMS. It's not suitable for those who don't meet the standard criteria for clinical TMS.

Inclusion Criteria

I have Major Depressive Disorder and improved significantly after TMS Therapy at Butler Hospital.

Participant Groups

The study tests if using real-time assessments through smartphones can help schedule maintenance TMS sessions effectively. Patients will either just be monitored weekly or receive additional TMS treatments when an algorithm detects symptom worsening over one year.

2Treatment groups

Experimental Treatment

Active Control

Group I: EMA+Maintenance TMSExperimental Treatment2 Interventions

Weekly EMA monitoring and a cluster of 5 maintenance sessions scheduled if/when PHQ9 scores reach threshold, per algorithm. Participants continue other concurrent treatment as usual (TAU) with medications, psychotherapy, etc per outpatient clinicians.

Group II: EMA onlyActive Control1 Intervention

Weekly EMA monitoring without scheduled maintenance TMS. Participants in this arm may get TMS retreatment according to current standard of care (i.e., through their insurance coverage). Participants continue other concurrent treatment as usual (TAU) with medications, psychotherapy, etc per outpatient clinicians.