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Maintenance TMS for Depression

N/A

Recruiting

Led By Linda Carpenter, MD

Research Sponsored by Butler Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with primary Major Depressive Disorder who responded (50% drop in score from pre-treatment baseline to final score on depression scale) to a standard acute course of TMS Therapy at Butler Hospital.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial evaluates using EMA to schedule maintenance TMS sessions for MDD patients who responded to initial TMS. Weekly PHQ-9 scores will be monitored and TMS sessions offered when symptoms worsen. The trial lasts one year with TMS as adjunct to usual MDD treatments.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the side effects are not detailed here, typical TMS may include headaches, scalp discomfort during treatment, tingling or spasms of facial muscles, lightheadedness, and in rare cases seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Weeks in Response Range

Trial Design

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Butler HospitalLead Sponsor

129 Previous Clinical Trials

16,388 Total Patients Enrolled

31 Trials studying Depression

6,359 Patients Enrolled for Depression

Linda Carpenter, MDPrincipal InvestigatorButler Hospital

5 Previous Clinical Trials

229 Total Patients Enrolled

2 Trials studying Depression

46 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for participation in this trial?

"As attested to by clinicaltrials.gov, this medical experiment is currently seeking out participants with its initial posting on September 25th 2023 and most recent update on November 17th 2023."

Answered by AI

How many individuals have enrolled in this clinical experiment so far?

"Yes, according to clinicaltrials.gov, this research is actively seeking participants and was initially posted on September 25th 2023 before being last modified November 17th 2023. The trial requires a total of 30 patients from one specific site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EMA-Guided Maintenance TMS for Depression

2023. "EMA-Guided Maintenance TMS for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145594.

All > Depression Boston