VGR Accelerated TMS Treatment for Depression (VAiT)

Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Device: iTBS (intermittent theta-burst stimulation)

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melker Hagsäter, MD, MSc, PhD; Phone Number: +46 3039 8000; Email: melker.hagsater@vgregion.se

Study Locations

• Sweden
  • Kungälv, Sweden
    • Recruiting
    • Kungälv Hospital
    • Contact: Melker Hagsäter; Phone Number: +46 10441 00 00; Email: melker.hagsater@vgregion.se
  • Skövde, Sweden
    • Recruiting
    • Hospital of Skövde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accelerated iTBS protocol; 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); 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.
Active Comparator: Routine iTBS protocol; 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); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Uppsala University; Göteborg University; The Gothenburg Society of Medicine
• Investigators: Principal Investigator: Melker Hagsäter, MD, MSc, PhD, Västra Götaland Regional Council

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Depression; rTMS; iTBS
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: VAiT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes