Clinical trial NCT03718013: Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS)
Official title: Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS); Randomized Controlled Equivalence Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Sveti Ivan Psychiatric Hospital
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores
timeFrame: 8 weeks
Secondary outcomes:
measure: Treatment response
timeFrame: 8 weeks
measure: The proportion of patients who experienced complete remission of the disease
timeFrame: 8 weeks
measure: Percentage improvement in BDI-II scores
timeFrame: 8 weeks
measure: Change in perceived quality of life (EQ-5D-5L scale)
timeFrame: 8 weeks
measure: Change in cognitive functions (MoCA test)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: PB Sveti Ivan
Study officials:
References: