臨床研究等提出・公開システム

Maintenance repetitive transcranial magnetic stimulation (rTMS) for
treatment-resistant depression: a multisite, prospective,
non-randomized longitudinal study (mTMS-D)

Maintenance repetitive transcranial magnetic stimulation (rTMS) for
treatment-resistant depression (mTMS-D)

Hayashi Daisuke

National Center of Neurology and Psychiatry Hospital

4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan.

dhayashi@ncnp.go.jp

Kazuki Nemoto

Satt Co., Ltd

ACN Shinjuku Building 5, 2-12-8, Shinjuku, Shinjukuku, Tokyo, Japan.

+81-3-5312-5026

mtmsd@sa-tt.co.jp

Recruiting

May. 01, 2022

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Those who:
1) are aged >=18 and have responded or remitted
by acute repetitive transcranial magnetic
stimulation (rTMS) therapy conducted in
accordance with the guidelines for the proper
use of rTMS
2) are willing to adhere to the treatment schedule
if the patients wish to receive maintenance rTMS
therapy

Those who:
1) are in pregnancy
2) have significant suicidal ideation (HAMD17
suicide item score of 3 or higher)
3) experienced serious adverse events during
acute rTMS therapy
4) are deemded inappropriate to participate by
judgement of principal investigator

Both

Depression

After acute rTMS therapy, maintenance rTMS
therapy will be administered for 12 months:
once a week for the first 6 months and once
every two weeks for the latter 6 months.

Depression

Transcranial magnetic stimulation

D003863

D050781

Rates of relapse/recurrence up to 12 months after
enrollment

1) relapse/recurrence rates at 3, 6, and 9 months
after enrollment
(subjects who relapsed/recurred prior to each
assessment period will be treated as relapsing
/recurring thereafter.)
2) response rates at 3, 6, 9, and 12 months after
enrollment
3) remission rates at 3, 6, 9, and 12 months after
enrollment
4) change in the scores of HAMD17, MADRS,
QIDS, and PHQ-9 after enrollment
5) period from enrollment until relapse
/recurrence
6) adverse events
7) malfunction

+81-42-341-2712-7828

Dec. 03, 2021

none