Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)

Early Phase 1

Not yet recruiting

• Conditions: Major Depressive Disorder

• Registration Number: NCT06961851
• Lead Sponsor: University of Minnesota

Brief Summary

This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist.

The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age between 18 and 70 years old
• Current patient of SLP Clinic
• Diagnosis of Unipolar Depression
• Have tried at least 1 antidepressant
• Ability to maintain stable medication regimen for duration of study

Exclusion Criteria

• Has received TMS in the last 3 months
• Diagnosis of Bipolar Depression
• Any lifetime psychosis or mania
• Recent suicide attempt within 90 days of study visit
• Use of Benzodiazepines in past 4 weeks
• Presence of any contraindication to TMS assessed by the TMS Adult Safety Screen including individual history of uncontrolled seizures
• Current or history of alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in depressive symptoms	baseline and 6 weeks	assessed via the PHQ9, comparing baseline to end of treatment and 6 weeks post treatment.

Secondary Outcome Measures

Name	Time	Method
Durability data of aTMS	0, 1, 2, 4, and 6 weeks post treatment
Dropout rate	6 weeks	will be calculated via completion rates