MAjor Depressive Disorder
Conditions
Keywords
Transcranial Magnetic Stimulation
Brief summary
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
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))
Interventions
DEVICEdTMS
Sponsors
Section for Affective Disorders; Northern Stockholm Psychiatry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* see above
Exclusion criteria
* see above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) score | baseline to last visit (treatment session 20, an average of four weeks) | MADRS baseline - MADRS last visit (treatment session 20) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) response | last visit (treatment session 20, an average of four weeks) | fraction of subjects with \>50% decrease in MADRS |
| Montgomery Asberg Depression Rating Scale (MADRS) remission | last visit (treatment session 20, an average of four weeks) | fraction of subjects with MADRS \<10 points |
| Clinical Global Impression Severity (CGI-S) | baseline to last visit (treatment session 20, an average of four weeks) | CGI-Sbaseline - CGI-S last visit (treatment session 20) |
| memory subjective | last visit (treatment session 20, an average of four weeks) | GSE-my at last visit |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | baseline to last visit (treatment session 20, an average of four weeks) | systematic safety evaluation and registration of side effects |
| memory objective | baseline to last visit (treatment session 20, an average of four weeks) | CPRS memory item at baseline - CPRS memory item at last visit |
Countries
Sweden
Outcome results
None listed