Accelerated iTBS for Depression in routine care
Official title: Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
Run by Vastra Gotaland Region · NCT07449338 · Data updated 2026-11-12
This study tests whether an accelerated iTBS treatment can help people with depression when used in regular clinical practice.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 3 sites (Gothenburg and 2 other locations) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07449338 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a diagnosed depression who are indicated for TMS and able to provide informed consent.
✕Probably not a fit
Patients with contraindications to TMS or those unlikely to complete follow-up may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will evaluate the effectiveness and tolerability of an accelerated iTBS protocol delivered in standard clinical settings. Participants receive 600 stimulation pulses per session, totaling 30 sessions over 5 to 14 treatment days, with follow-up assessments up to 6 months from start. Patients are monitored through self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months. Inclusion requires a depression diagnosis confirmed by MINI and suitability for TMS, while major exclusions relate to ferromagnetic implants or other factors increasing follow-up risk. The study is conducted across multiple hospitals in Sweden and aims to enroll up to 150 patients, with a target of at least 36 participants.
Why it matters
Potential benefit: If successful, accelerated iTBS could shorten treatment time while maintaining benefit for depression.
How similar studies have gone: Previous iTBS research supports effectiveness in depression, but accelerated protocols in routine care are being explored and may yield varied results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.) * provision of signed informed consent form * indication for TMS is depression Exclusion Criteria: * 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 * any condition that seriously increases the risk of non-compliance or loss of follow-up
Where it's running
-
Sahlgrenska University Hospital
Gothenburg, Sweden Recruiting -
Kungälv Hospital, Kungälv
Kungälv, Sweden Recruiting -
Central Hospital Växjö
Vaxjo, Sweden Recruiting
Study contacts
- Study coordinator: Melker Hagsäter, MD, MSc, PhD, PhD
- Email: melker.hagsater@vgregion.se
- Phone: +46 3039 8000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.