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

NCT ID: NCT03718013

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-11-01

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

accelerated dTMS

Group Type: EXPERIMENTAL

accelerated deep TMS

Intervention Type: DEVICE

subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks

standard dTMS

Group Type: ACTIVE_COMPARATOR

standard deep TMS

Intervention Type: DEVICE

standard deep TMS treatment: once a day, during 4 weeks

Interventions

accelerated deep TMS

subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks

Intervention Type: DEVICE

standard deep TMS

standard deep TMS treatment: once a day, during 4 weeks

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sveti Ivan Psychiatric Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PB Sveti Ivan

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

acceleratedDTMS

Identifier Type: -

Identifier Source: org_study_id