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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.
population: inclusion 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | dTMS standard protocol 10 min session |
|
| B | Active Comparator | dTMS standard protocol 20 min session |
|
| C | Active Comparator | dTMS standard protocol 40 min session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dTMS | Device |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| johan lundberg, MD PhD | Norra Stockholms Psykiatri and Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norra Stockholms Psykiatri | Stockholm | 11251 | Sweden |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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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) |