VGR Accelerated TMS Treatment for Depression
Recruiting · NCT06138678 · Interventional (participants receive a specific treatment) · Lead sponsor: Vastra Gotaland Region
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- Kungälv Hospital - Kungälv, Sweden
- Hospital of Skövde - Skövde, Sweden