MAjor Depressive Disorder Clinical Trial
Official title:
Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
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.
population: inclusion criteria:
1. Ongoing episode of MDD (ICD10 F32.x) according to MINI/SCID1.
2. Montgomery Asberg Depression Rating Scale (MADRS) score 20-60
3. 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))
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