VGR Accelerated TMS Treatment for Depression

Depression Clinical Trial

— VAiT  

Official title:

Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138678
• Other study ID #: VAiT
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: Melker Hagsäter, MD, MSc, PhD
• Phone: +46 3039 8000
• Email: melker.hagsater[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	Kungälv Hospital	Kungälv
Sweden	Hospital of Skövde	Skövde

Sponsors (4)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Göteborg University, The Gothenburg Society of Medicine, Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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