Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
146 participants
INTERVENTIONAL
2024-01-15
2027-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Accelerated High-dose Sequential Bilateral Theta Burst Stimulation for Treatment Resistant Depression
NCT05811104
Long-term Bilateral Theta Burst Stimulation for the Treatment of Major Depression
NCT01153139
Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression
NCT01240083
Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
NCT06528938
Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network
NCT05224206
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Accelerated iTBS protocol
Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 1200 pulses per session; total duration of 6 min 40 s over the left DLPFC (F3), given in 2 sessions per day (50 min interval) on 15 week days.
iTBS (intermittent theta-burst stimulation)
The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil.
The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.
Routine iTBS protocol
Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in 1 session per day on 30 week days.
iTBS (intermittent theta-burst stimulation)
The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil.
The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
iTBS (intermittent theta-burst stimulation)
The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil.
The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Göteborg University
OTHER
Uppsala University
OTHER
The Swedish Society of Medicine
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Melker Hagsäter, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Västra Götaland Regional Council
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kungälv Hospital
Kungälv, , Sweden
Hospital of Skövde
Skövde, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VAiT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.