Recruiting

VGR Accelerated TMS Treatment for Depression

ClinicalTrials.gov IDNCT06138678

PhaseNA

Enrollment146

SponsorVastra Gotaland Region

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Depression

About this study

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 outcomes

Difference in MADRS-S from baseline to three weeks after first iTBS treatment (3 weeks)

Eligibility information

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

Study locations

Kungälv Hospital, Kungälv, Sweden
Hospital of Skövde, Skövde, Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.