VGR Accelerated TMS Treatment for Depression

Study Overview
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Brief Summary
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Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well documented method for treatment of depression. The aim of the study is to assess the effect of an accelerated iTBS protocol compared to a routine iTBS protocol. In the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days). Participants (n = 146) will be recruited among patients referred to iTBS and randomized to treatment. Participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. A psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. Patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of treatment.

Official Title
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Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

Conditions
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Depression

Intervention / Treatment
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* Device: iTBS (intermittent theta-burst stimulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.) MADRS-S >= 20 unchanged medication last month unchanged psychological treatment last month admitted to psychiatric ward last month no ECT or TMS last six months provision of signed informed consent form indication for TMS is depression Exclusion Criteria: addiction (illicit drugs or alcohol) pregnancy epilepsy conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil implanted device that is activated or controlled in any way by physiological signals implanted mediation pumps intracardiac lines, even when removed regular use of benzodiazepines any condition that seriously increases the risk of non-compliance or loss of follow-up

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated iTBS protocol<br>Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 1200 pulses per session; total duration of 6 min 40 s over the left DLPFC (F3), given in 2 sessions per day (50 min interval) on 15 week days. | Device: iTBS (intermittent theta-burst stimulation)<br>* The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.<br>|
| Active Comparator: Routine iTBS protocol<br>Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in 1 session per day on 30 week days. | Device: iTBS (intermittent theta-burst stimulation)<br>* The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in MADRS-S from baseline to three weeks after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in MADRS-S from baseline to one week after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 1 week | 
| Difference in MADRS-S from baseline to two weeks after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 2 weeks | 
| Difference in MADRS-S from baseline to four weeks after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 4 weeks | 
| Difference in MADRS-S from baseline to five weeks after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 5 weeks | 
| Difference in MADRS-S from baseline to six weeks after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 6 weeks | 
| Difference in MADRS-S from baseline to six months after last iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 6 months | 
| Difference in QIDS-SR from baseline to one week after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 1 week | 
| Difference in QIDS-SR from baseline to two weeks after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 2 weeks | 
| Difference in QIDS-SR from baseline to three weeks after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 3 weeks | 
| Difference in QIDS-SR from baseline to four weeks after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 4 weeks | 
| Difference in QIDS-SR from baseline to five weeks after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 5 weeks | 
| Difference in QIDS-SR from baseline to six weeks after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 6 weeks | 
| Difference in QIDS-SR from baseline to six months after first iTBS treatment | The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms | 6 months | 
| Difference in SDS from baseline to six weeks after first iTBS treatment | The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment | 6 weeks | 
| Difference in SDS from baseline to six months after first iTBS treatment | The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment | 6 months | 
| Difference in EQ-VAS from baseline to three weeks after first iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 3 weeks | 
| Difference in EQ-VAS from baseline to six weeks after first iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 6 weeks | 
| Difference in EQ-VAS from baseline to six months after first iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 6 months | 
| Difference in CGI-S from baseline to three weeks after first iTBS treatment | The Clinical Global Impression - Severity scale (CGI-S) is a clinical rating scale (0-7 points), where a higher score indicates more severe symptoms | 3 weeks | 
| Difference in CGI-S from baseline to six weeks after first iTBS treatment | The Clinical Global Impression - Severity scale (CGI-S) is a clinical rating scale (0-7 points), where a higher score indicates more severe symptoms | 6 weeks | 
| Difference in CGI-I from baseline to three weeks after first iTBS treatment | The Clinical Global Impression - Improvement scale (CGI-I) is a clinical rating scale (0-7 points) of symptom improvement (lower score)/worsening (higher score) compared to baseline | 3 weeks | 
| Difference in CGI-I from baseline to six weeks after first iTBS treatment | The Clinical Global Impression - Improvement scale (CGI-I) is a clinical rating scale (0-7 points) of symptom improvement (lower score)/worsening (higher score) compared to baseline | 6 weeks | 
| Number of patients in remission three weeks after first iTBS treatment | A patient with a MADRS-S score of < 10 is considered to be in remission | 3 weeks | 
| Number of patients in remission six weeks after first iTBS treatment | A patient with a MADRS-S score of < 10 is considered to be in remission | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iTBS, rTMS, Depression