Maintenance rTMS for Depression (Maitr-De)

NARecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Major Depressive DisorderTreatment Resistant Depression
Interventions
DEVICE

Transcranial Magnetic Stimulation (TMS) - Standard maintenance rTMS:

In this approach, patients who were treated with rTMS five days per week during their acute episode receive less frequent treatments during a taper period (for example treatment three days per week followed by two sessions per week) with a gradual transition into a maintenance schedule. For example, the maintenance schedule might begin with a single weekly session for one or two months and then the intensity is reduced to one session every two weeks (and possibly then one session every three or four weeks).

DEVICE

Transcranial Magnetic Stimulation (TMS) - Clustered maintenance rTMS:

Clustered maintenance rTMS typically involves around 4 TMS sessions applied over 2 days, at 1-month intervals. Our team initially developed this approach based upon preclinical TMS studies (for example (Maeda et al. 2000)) suggesting that rTMS treatment effects may accumulate when applied over multiple sessions in a shorter period of time (Maeda et al. 2000).

DEVICE

Transcranial Magnetic Stimulation (TMS) -- Sham maintenance rTMS

Sham treatment will be administered as either standard or clustered maintenance rTMS for 6 months period using a sham coil. The intervention target will be located via a Brainsight TMS Navigator (Brainsight, Montreal, Canada). For safety reasons, the individual TMS intensity will be limited to 130% of the individual resting motor threshold.

Trial Locations (3)

2601

RECRUITING

Australian National University, Canberra

10065

RECRUITING

Weill Cornell Medicine, New York

92127

RECRUITING

University of California, San Diego, San Diego

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

University of California, San Diego

OTHER