Clinical trial NCT06138678: VGR Accelerated TMS Treatment for Depression
Official title: Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: iTBS
rTMS
Depression
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
name: Uppsala University
name: The Swedish Society of Medicine
First posted: 2023-11-18
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Difference in MADRS-S from baseline to three weeks after first iTBS treatment
timeFrame: 3 weeks
Secondary outcomes:
measure: Difference in MADRS-S from baseline to one week after first iTBS treatment
timeFrame: 1 week
measure: Difference in MADRS-S from baseline to two weeks after first iTBS treatment
timeFrame: 2 weeks
measure: Difference in MADRS-S from baseline to four weeks after first iTBS treatment
timeFrame: 4 weeks
measure: Difference in MADRS-S from baseline to five weeks after first iTBS treatment
timeFrame: 5 weeks
measure: Difference in MADRS-S from baseline to six weeks after first iTBS treatment
timeFrame: 6 weeks
measure: Difference in MADRS-S from baseline to six months after last iTBS treatment
timeFrame: 6 months
measure: Difference in QIDS-SR from baseline to one week after first iTBS treatment
timeFrame: 1 week
measure: Difference in QIDS-SR from baseline to two weeks after first iTBS treatment
timeFrame: 2 weeks
measure: Difference in QIDS-SR from baseline to three weeks after first iTBS treatment
timeFrame: 3 weeks
measure: Difference in QIDS-SR from baseline to four weeks after first iTBS treatment
timeFrame: 4 weeks
measure: Difference in QIDS-SR from baseline to five weeks after first iTBS treatment
timeFrame: 5 weeks
measure: Difference in QIDS-SR from baseline to six weeks after first iTBS treatment
timeFrame: 6 weeks
measure: Difference in QIDS-SR from baseline to six months after first iTBS treatment
timeFrame: 6 months
measure: Difference in SDS from baseline to six weeks after first iTBS treatment
timeFrame: 6 weeks
measure: Difference in SDS from baseline to six months after first iTBS treatment
timeFrame: 6 months
measure: Difference in EQ-VAS from baseline to three weeks after first iTBS treatment
timeFrame: 3 weeks
measure: Difference in EQ-VAS from baseline to six weeks after first iTBS treatment
timeFrame: 6 weeks
measure: Difference in EQ-VAS from baseline to six months after first iTBS treatment
timeFrame: 6 months
measure: Difference in CGI-S from baseline to three weeks after first iTBS treatment
timeFrame: 3 weeks
measure: Difference in CGI-S from baseline to six weeks after first iTBS treatment
timeFrame: 6 weeks
measure: Difference in CGI-I from baseline to three weeks after first iTBS treatment
timeFrame: 3 weeks
measure: Difference in CGI-I from baseline to six weeks after first iTBS treatment
timeFrame: 6 weeks
measure: Number of patients in remission three weeks after first iTBS treatment
timeFrame: 3 weeks
measure: Number of patients in remission six weeks after first iTBS treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kungälv
country: Sweden
facility: Kungälv Hospital
city: Skövde
country: Sweden
facility: Hospital of Skövde
Study officials:
affiliation: Västra Götaland Regional Council
name: Melker Hagsäter, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: