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Recruiting NCT06138678

VGR Accelerated TMS Treatment for Depression

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTBS (intermittent theta-burst stimulation).
Who it may be relevant to
Registry conditions: Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Difference in MADRS-S from baseline to three weeks after first iTBS treatment [Time frame: 3 weeks]
Secondary outcome measures (12)
  • Difference in MADRS-S from baseline to one week after first iTBS treatment [Time frame: 1 week]
  • Difference in MADRS-S from baseline to two weeks after first iTBS treatment [Time frame: 2 weeks]
  • Difference in MADRS-S from baseline to four weeks after first iTBS treatment [Time frame: 4 weeks]
  • Difference in MADRS-S from baseline to five weeks after first iTBS treatment [Time frame: 5 weeks]
  • Difference in MADRS-S from baseline to six weeks after first iTBS treatment [Time frame: 6 weeks]
  • Difference in MADRS-S from baseline to six months after last iTBS treatment [Time frame: 6 months]
  • Difference in QIDS-SR from baseline to one week after first iTBS treatment [Time frame: 1 week]
  • Difference in QIDS-SR from baseline to two weeks after first iTBS treatment [Time frame: 2 weeks]
  • Difference in QIDS-SR from baseline to three weeks after first iTBS treatment [Time frame: 3 weeks]
  • Difference in QIDS-SR from baseline to four weeks after first iTBS treatment [Time frame: 4 weeks]
  • Difference in QIDS-SR from baseline to five weeks after first iTBS treatment [Time frame: 5 weeks]
  • Difference in QIDS-SR from baseline to six weeks after first iTBS treatment [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 2 centers
  • Kungälv Hospital — Kungälv
  • Hospital of Skövde — Skövde

Identifiers

NCT: NCT06138678 · VAiT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗