VGR Accelerated TMS Treatment for Depression

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: iTBS (intermittent theta-burst stimulation)

• Registration Number: NCT06138678
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2024-01-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-01-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated iTBS protocol	iTBS (intermittent theta-burst stimulation)	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.
Routine iTBS protocol	iTBS (intermittent theta-burst stimulation)	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.

Primary Outcome Measures

Name	Time	Method
Difference in MADRS-S from baseline to three weeks after first iTBS treatment	3 weeks	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

Secondary Outcome Measures

Name	Time	Method
Difference in CGI-I from baseline to three weeks after first iTBS treatment	3 weeks	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
Difference in QIDS-SR from baseline to six weeks after first iTBS treatment	6 weeks	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
Difference in QIDS-SR from baseline to six months after first iTBS treatment	6 months	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
Difference in EQ-VAS from baseline to six weeks after first iTBS treatment	6 weeks	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
Difference in MADRS-S from baseline to two weeks after first iTBS treatment	2 weeks	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
Difference in MADRS-S from baseline to six weeks after first iTBS treatment	6 weeks	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
Difference in QIDS-SR from baseline to two weeks after first iTBS treatment	2 weeks	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
Difference in SDS from baseline to six months after first iTBS treatment	6 months	The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment
Difference in CGI-S from baseline to six weeks after first iTBS treatment	6 weeks	The Clinical Global Impression - Severity scale (CGI-S) is a clinical rating scale (0-7 points), where a higher score indicates more severe symptoms
Difference in CGI-I from baseline to six weeks after first iTBS treatment	6 weeks	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
Number of patients in remission three weeks after first iTBS treatment	3 weeks	A patient with a MADRS-S score of \< 10 is considered to be in remission
Difference in MADRS-S from baseline to five weeks after first iTBS treatment	5 weeks	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
Difference in MADRS-S from baseline to six months after last iTBS treatment	6 months	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
Difference in QIDS-SR from baseline to one week after first iTBS treatment	1 week	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
Difference in QIDS-SR from baseline to four weeks after first iTBS treatment	4 weeks	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
Difference in QIDS-SR from baseline to five weeks after first iTBS treatment	5 weeks	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
Difference in SDS from baseline to six weeks after first iTBS treatment	6 weeks	The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment
Difference in EQ-VAS from baseline to three weeks after first iTBS treatment	3 weeks	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
Difference in MADRS-S from baseline to one week after first iTBS treatment	1 week	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
Difference in QIDS-SR from baseline to three weeks after first iTBS treatment	3 weeks	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
Difference in EQ-VAS from baseline to six months after first iTBS treatment	6 months	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
Difference in MADRS-S from baseline to four weeks after first iTBS treatment	4 weeks	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
Difference in CGI-S from baseline to three weeks after first iTBS treatment	3 weeks	The Clinical Global Impression - Severity scale (CGI-S) is a clinical rating scale (0-7 points), where a higher score indicates more severe symptoms
Number of patients in remission six weeks after first iTBS treatment	6 weeks	A patient with a MADRS-S score of \< 10 is considered to be in remission

Trial Locations

Locations (2)

Hospital of Skövde; 🇸🇪 Skövde, Sweden

Kungälv Hospital; 🇸🇪 Kungälv, Sweden