RecruitingNot ApplicableNCT06138678

VGR Accelerated TMS Treatment for Depression

Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression

Sponsor

Vastra Gotaland Region

Enrollment

146 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Depression

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an accelerated form of transcranial magnetic stimulation (TMS) for treating depression in hospitalized patients who have not improved with medication or other treatments. TMS uses magnetic pulses to stimulate specific areas of the brain involved in mood regulation, and this study explores a faster delivery schedule. **You may be eligible if...** - You have a confirmed diagnosis of depression - Your depression score on a clinical scale (MADRS-S) is 20 or higher, indicating moderate-to-severe symptoms - Your medication and any psychological therapy have been unchanged for the past month - You were admitted to a psychiatric ward in the past month - You have not had ECT or TMS treatment in the past 6 months - TMS has been recommended as appropriate for your care **You may NOT be eligible if...** - You have an addiction to alcohol or illicit drugs - You are pregnant - You have epilepsy - You have metal implants in your head or within 30 cm of the treatment coil - You have an implanted electronic device (such as a pacemaker) that could be affected by the magnetic field Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiTBS (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.