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Completed

NCT Number: NCT03718013

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PB Sveti Ivan

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

accelerated deep TMS

Device

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

standard deep TMS

Device

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

Primary outcomes

  1. Percentage improvement in the Hamilton Rating Scale for Depression (HAM-D) scores

    Time frame: 8 weeks

    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).

Secondary outcomes

  1. Treatment response

    Time frame: 8 weeks

    ≥50% decrease in scores on the Hamilton Rating Scale for Depression (HAM-D)

  2. The proportion of patients who experienced complete remission of the disease

    Time frame: 8 weeks

  3. Percentage improvement in BDI-II scores

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

  5. Change in cognitive functions (MoCA test)

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Sveti Ivan Psychiatric Hospital

Other

Registry information

Official study title

Efficacy and Safety of Accelerated Transcranial Magnetic Stimulation With H1-coil (dTMS); Randomized Controlled Equivalence Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2018
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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