Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03718013
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-10-16
Brief Title:
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil dTMS
Sponsor:
Sveti Ivan Psychiatric Hospital
Organization:
Sveti Ivan Psychiatric Hospital
Study Overview
Official Title:
Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil dTMS Randomized Controlled Equivalence Trial
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with H1-coil deep TMS for treatment of patients diagnosed with major depressive disorder MDD Subjects will be randomized into two groups experimental treated with accelerated deep TMS twice a day 6-8 hours between two applications during 2 weeks and control group standard deep TMS treatment once a day during 4 weeks Participants and designated clinicians will complete a battery of instruments that measure relevant symptoms HAM-D17 and BDI-II scales global functioning CGI and PHQ-9 scales quality of life EQ-5D-5L questionnaire and cognitive functions MoCA test Measurements will be done in 4 time points after the inclusion after the first week of treatment after the second week the end of treatment for experimental group after the fourth week the end of treatment for control group and after 1 month follow-up for both groups Interim data analysis is planned at the time when at least 30 participants are involved in both groups Patients whose baseline score on HAM-D17 is equal or greater than 24 very severe depression will be included in another study they will be treated with accelerated deep TMS twice a day during 4 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None