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NCT Number: NCT06138678

VGR Accelerated TMS 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kungälv Hospital, Kungälv, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iTBS (intermittent theta-burst stimulation)

Device

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.

Primary outcomes

  1. Difference in MADRS-S from baseline to three weeks after first iTBS treatment

    Time frame: 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 outcomes

  1. Difference in MADRS-S from baseline to one week after first iTBS treatment

    Time frame: 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

  2. Difference in MADRS-S from baseline to two weeks after first iTBS treatment

    Time frame: 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

  3. Difference in MADRS-S from baseline to four weeks after first iTBS treatment

    Time frame: 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

  4. Difference in MADRS-S from baseline to five weeks after first iTBS treatment

    Time frame: 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

  5. Difference in MADRS-S from baseline to six weeks after first iTBS treatment

    Time frame: 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

  6. Difference in MADRS-S from baseline to six months after last iTBS treatment

    Time frame: 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

  7. Difference in QIDS-SR from baseline to one week after first iTBS treatment

    Time frame: 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

  8. Difference in QIDS-SR from baseline to two weeks after first iTBS treatment

    Time frame: 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

  9. Difference in QIDS-SR from baseline to three weeks after first iTBS treatment

    Time frame: 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

  10. Difference in QIDS-SR from baseline to four weeks after first iTBS treatment

    Time frame: 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

  11. Difference in QIDS-SR from baseline to five weeks after first iTBS treatment

    Time frame: 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

  12. Difference in QIDS-SR from baseline to six weeks after first iTBS treatment

    Time frame: 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

  13. Difference in QIDS-SR from baseline to six months after first iTBS treatment

    Time frame: 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

  14. Difference in SDS from baseline to six weeks after first iTBS treatment

    Time frame: 6 weeks

    The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment

  15. Difference in SDS from baseline to six months after first iTBS treatment

    Time frame: 6 months

    The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment

  16. Difference in EQ-VAS from baseline to three weeks after first iTBS treatment

    Time frame: 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

  17. Difference in EQ-VAS from baseline to six weeks after first iTBS treatment

    Time frame: 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

  18. Difference in EQ-VAS from baseline to six months after first iTBS treatment

    Time frame: 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

  19. Difference in CGI-S from baseline to three weeks after first iTBS treatment

    Time frame: 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

  20. Difference in CGI-S from baseline to six weeks after first iTBS treatment

    Time frame: 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

  21. Difference in CGI-I from baseline to three weeks after first iTBS treatment

    Time frame: 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

  22. Difference in CGI-I from baseline to six weeks after first iTBS treatment

    Time frame: 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

  23. Number of patients in remission three weeks after first iTBS treatment

    Time frame: 3 weeks

    A patient with a MADRS-S score of < 10 is considered to be in remission

  24. Number of patients in remission six weeks after first iTBS treatment

    Time frame: 6 weeks

    A patient with a MADRS-S score of < 10 is considered to be in remission

Study contacts

Contact information is provided by the study sponsor or research team.

Melker Hagsäter, MD, MSc, PhD

CONTACT

[email protected]

+46 3039 8000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University
  • The Swedish Society of Medicine
  • Uppsala University

Registry information

Official study title

Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

Acronym: VAiT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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