Accelerated TMS treatment for depression
Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression
This study is testing if a faster treatment using brain stimulation can help people with depression feel better compared to the usual slower method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 2 sites (Kungälv and 1 other locations) |
| Trial ID | NCT06138678 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an accelerated intermittent theta burst stimulation (iTBS) protocol compared to a routine iTBS protocol for treating depression. Participants will receive either 1200 pulses per session twice a day over 15 days or 600 pulses per session once a day over 30 days. A total of 146 patients diagnosed with depression will be recruited and randomized to one of the treatment protocols. Their depressive symptoms will be assessed by psychiatrists at 3 and 6 weeks post-treatment, along with self-rating questionnaires throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with depression who meet specific inclusion criteria and have not undergone recent TMS or ECT.
Not a fit: Patients with a history of substance abuse, pregnancy, epilepsy, or certain implanted devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a faster and more effective option for patients suffering from depression.
How similar studies have performed: Previous studies have shown promising results with iTBS for depression, suggesting that this accelerated approach may also be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kungälv and 1 other locations
- Kungälv Hospital — Kungälv, Sweden (Recruiting)
- Hospital of Skövde — Skövde, Sweden (Recruiting)
Study contacts
- Principal investigator: Melker Hagsäter, MD, MSc, PhD — Västra Götaland Regional Council
- Study coordinator: Melker Hagsäter, MD, MSc, PhD
- Email: melker.hagsater@vgregion.se
- Phone: +46 3039 8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.