Clinical Effect of Deep Transcranial Magnetic Stimulation (dTMS) in Three Different Doses for the Treatment of Major Depressive Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- MAjor Depressive Disorder
- Sponsor
- Section for Affective Disorders; Northern Stockholm Psychiatry
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Montgomery Asberg Depression Rating Scale (MADRS) score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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))
Investigators
Johan Lundberg
Section head, associate professor, MD PhD
Section for Affective Disorders; Northern Stockholm Psychiatry
Eligibility Criteria
Inclusion Criteria
- •see above
Exclusion Criteria
- •see above
Outcomes
Primary Outcomes
Montgomery Asberg Depression Rating Scale (MADRS) score
Time Frame: baseline to last visit (treatment session 20, an average of four weeks)
MADRS baseline - MADRS last visit (treatment session 20)
Secondary Outcomes
- Clinical Global Impression Severity (CGI-S)(baseline to last visit (treatment session 20, an average of four weeks))
- Montgomery Asberg Depression Rating Scale (MADRS) remission(last visit (treatment session 20, an average of four weeks))
- memory objective(baseline to last visit (treatment session 20, an average of four weeks))
- memory subjective(last visit (treatment session 20, an average of four weeks))
- Montgomery Asberg Depression Rating Scale (MADRS) response(last visit (treatment session 20, an average of four weeks))
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](baseline to last visit (treatment session 20, an average of four weeks))