NCT03718013

Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)

Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS); Randomized Controlled Equivalence Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Sveti Ivan Psychiatric Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	accelerated deep TMS	subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks
DEVICE	standard deep TMS	standard deep TMS treatment: once a day, during 4 weeks

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-07-31
• Completion: 2019-11-01
• First posted: 2018-10-24
• Last updated: 2020-02-12

Locations

1 site across 1 country: Croatia