Clinical Effect of dTMS in Major Depressive Disorder

Study Overview
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Brief Summary
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Aim: To test if there is a relation between deep Transcranial Magnetic Stimulation (dTMS) dose and clinical effect on Major Depressive Disorder (MDD) Method: 30 patients with moderate to severe MDD without concurrent medication will be randomised to three different treatment protocols of dTMS. Symptom severity of MDD will be quantified before, during and after dTMS.

Detailed Description
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population: inclusion criteria: Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60 TMS safe exclusion criteria: 1. Bipolar disorder 2. Substance abuse 3. fluoxetine treatment last three weeks 4. Other major Central Nervous System (CNS) disorder 5. Acute medical disorders 6. previous TMS or Electro Convulsive Treatment (ECT) <2 months before inclusion ratings: MADRS at inclusion, baseline, weekly, at last visit Clinical Global Impression Severity (CGI-S) score at baseline, at last visit Global Self-Evaluation-Memory (GSE-My) at last visit Alcohol Use Disorder Identification Test (AUDIT-C) at inclusion EuroQual 5 Dimension (EQ5D) at baseline, at last visit Quick Inventory of Depressive Symptomatology Self Rating (QIDS-SR) baseline, weekly, last visit condition: Each subject is randomised to condition A, B or C of dTMS (Brainsway): half the standard protocol (10 min; A), standard protocol (20 min; B) or double standard protocol (40 min, C). 20 treatment sessions/subject. 10 subjects in each group. Primary endpoint: MADRS at baseline - MADRS at last visit (Intention TO Treat (ITT), Last Observation Carried Forward (LOCF))

Official Title
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Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder

Conditions
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MAjor Depressive Disorder

Intervention / Treatment
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* Device: dTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: see above Exclusion Criteria: see above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>dTMS standard protocol 10 min session | Device: dTMS<br> <br> |
| Active Comparator: B<br>dTMS standard protocol 20 min session | Device: dTMS<br> <br> |
| Active Comparator: C<br>dTMS standard protocol 40 min session | Device: dTMS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) score | MADRS baseline - MADRS last visit (treatment session 20) | baseline to last visit (treatment session 20, an average of four weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Severity (CGI-S) | CGI-Sbaseline - CGI-S last visit (treatment session 20) | baseline to last visit (treatment session 20, an average of four weeks) | 
| Montgomery Asberg Depression Rating Scale (MADRS) response | fraction of subjects with >50% decrease in MADRS | last visit (treatment session 20, an average of four weeks) | 
| Montgomery Asberg Depression Rating Scale (MADRS) remission | fraction of subjects with MADRS <10 points | last visit (treatment session 20, an average of four weeks) | 
| memory objective | CPRS memory item at baseline - CPRS memory item at last visit | baseline to last visit (treatment session 20, an average of four weeks) | 
| memory subjective | GSE-my at last visit | last visit (treatment session 20, an average of four weeks) | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | systematic safety evaluation and registration of side effects | baseline to last visit (treatment session 20, an average of four weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation