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

Sveti Ivan Psychiatric Hospital

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: accelerated deep TMS; Device: standard deep TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03718013

acceleratedDTMS

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2)
• current depressive episode lasts for at least 4 weeks
• HAM-D17 score ≥15
• CGI-Score ≥4
• inadequate response to antidepressant therapy

Exclusion criteria

• diagnosed psychotic disorder
• diagnosed depressive disorder with psychotic features
• diagnosed bipolar affective disorder
• diagnosed posttraumatic stress disorder
• diagnosed obsessive-compulsive disorder
• anxiety disorder or personality disorder as primary diagnoses
• alcohol or drug addiction
• neurological disorders and brain implants
• pregnancy
• former TMS treatment within 6 months
• unable to complete the questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

accelerated dTMS

Experimental group

Treatment:

Device: accelerated deep TMS

standard dTMS

Active Comparator group

Treatment:

Device: standard deep TMS