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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: accelerated deep TMS; Device: standard deep TMS

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • PB Sveti Ivan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: accelerated dTMS	Device: accelerated deep TMS; subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks
ACTIVE_COMPARATOR: standard dTMS	Device: standard deep TMS; standard deep TMS treatment: once a day, during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores	The Hamilton Rating Scale for Depression (HAM-D) is a clinician-administered depression assessment scale. The original version contains 17 items pertaining to symptoms of depression experienced over the past week. The items are scored either on a 3-point or 5-point scale, and all the values are summed to obtain a total scale score. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression (the maximum score being 52).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response	≥50% decrease in scores on the Hamilton Rating Scale for Depression (HAM-D)	8 weeks
The proportion of patients who experienced complete remission of the disease		8 weeks
Percentage improvement in BDI-II scores	The Beck Depression Inventory (BDI-II) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer is scored on a scale value of 0 to 3. All the values are summed to obtain a total scale score. Higher total scores indicate more severe depressive symptoms. Scores of 0-13 are considered as minimal depression,14-19 suggest mild depression, 20-28 moderate depression, and 29-63 severe depression.	8 weeks
Change in perceived quality of life (EQ-5D-5L scale)	The EQ-5D-5L is a standardised self-report measure of health status developed by the EuroQol Group. It consists of the descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises the 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression), and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent´s decision results in a 1-digit number expressing the level selected for that dimension. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (number 100) and 'the worst health you can imagine' (number 0). The respondents are asked to mark an X on the scale to indicate how their health is today and then to write the number they marked on the scale in the box below.	8 weeks
Change in cognitive functions (MoCA test)	The Montreal Cognitive Assessment (MoCA) is a one-page 30-point screening assessment for detecting cognitive impairment. It assesses several cognitive domains: the short-term memory recall task (5 points), visuospatial abilities (4 points), multiple aspects of executive functions (4 points), attention, concentration, and working memory (6 points), language (5 points), and orientation to time and place (6 points). A score of 26 or over is considered to be normal.	8 weeks

Collaborators and Investigators

• Sponsor: Sveti Ivan Psychiatric Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (ACTUAL): October 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: acceleratedDTMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No