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

NCT03718013 | Completed

• 1 other identifier: acceleratedDTMS
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Treatment response

  8 weeks

• The proportion of patients who experienced complete remission of the disease

  8 weeks

• Percentage improvement in BDI-II scores

  8 weeks

• Change in perceived quality of life (EQ-5D-5L scale)

  8 weeks

• Change in cognitive functions (MoCA test)

  8 weeks

Study Arms (2)

accelerated dTMS

EXPERIMENTAL

Device: accelerated deep TMS

standard dTMS

ACTIVE COMPARATOR

Device: standard deep TMS

Interventions

accelerated deep TMS DEVICE

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

accelerated dTMS

standard deep TMS DEVICE

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

standard dTMS

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sveti Ivan Psychiatric Hospital: lead

Study Sites (1)

PB Sveti Ivan

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 24, 2018
• Study Start: December 1, 2018
• Primary Completion: July 31, 2019
• Study Completion: November 1, 2019
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

CR (1)