VGR Accelerated TMS Treatment for Depression

Last updated: November 21, 2024
Sponsor: Vastra Gotaland Region
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

iTBS (intermittent theta-burst stimulation)

Clinical Study ID

NCT06138678
VAiT
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of depression verified through a Mini International NeuropsychiatricInterview (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

Exclusion Criteria:

  • addiction (illicit drugs or alcohol)

  • pregnancy

  • epilepsy

  • conductive ferromagnetic or other metals implanted in the head or within 30 cm ofthe 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 offollow-up

Study Design

Total Participants: 146
Treatment Group(s): 1
Primary Treatment: iTBS (intermittent theta-burst stimulation)
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
August 01, 2027

Connect with a study center

  • Kungälv Hospital

    Kungälv,
    Sweden

    Active - Recruiting

  • Hospital of Skövde

    Skövde,
    Sweden

    Active - Recruiting

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