Actively Recruiting
VGR Accelerated TMS Treatment for Depression
Led by Vastra Gotaland Region · Updated on 2024-11-25
146
Participants Needed
2
Research Sites
184 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
VGR Accelerated TMS Treatment for Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of depression verified through Mini International Neuropsychiatric Interview (M.I.N.I.)
- MADRS-S score of 20 or higher
- Medication unchanged for the last month
- Psychological treatment unchanged for the last month
- Admitted to psychiatric ward in the last month
- No electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the last six months
- Signed informed consent form provided
- Indication for TMS is depression
You will not qualify if you...
- Addiction to illicit drugs or alcohol
- Pregnancy
- Epilepsy
- Conductive ferromagnetic or other metal implants in the head or within 30 cm of the treatment coil
- Implanted devices activated or controlled by physiological signals
- Implanted medication pumps
- Intracardiac lines, even if removed
- Regular use of benzodiazepines
- Any condition that significantly increases risk of non-compliance or loss of follow-up
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Kungälv Hospital
Kungälv, Sweden
Actively Recruiting
2
Hospital of Skövde
Skövde, Sweden
Actively Recruiting
Research Team
M
Melker Hagsäter, MD, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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