Maintenance repetitive transcranial magnetic stimulation (rTMS) fortreatment-resistant depressio
Not Applicable
Recruiting
- Conditions
- DepressionD003863
- Registration Number
- JPRN-jRCT1032220048
- Lead Sponsor
- Kito Shinsuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rates of relapse/recurrence up to 12 months after<br>enrollment
- Secondary Outcome Measures
Name Time Method 1) relapse/recurrence rates at 3, 6, and 9 months<br>after enrollment<br>(subjects who relapsed/recurred prior to each<br>assessment period will be treated as relapsing<br>/recurring thereafter.)<br>2) response rates at 3, 6, 9, and 12 months after<br>enrollment<br>3) remission rates at 3, 6, 9, and 12 months after<br>enrollment<br>4) change in the scores of HAMD17, MADRS,<br>QIDS, and PHQ-9 after enrollment<br>5) period from enrollment until relapse<br>/recurrence<br>6) adverse events<br>7) malfunction