DepressionNCT07449338
Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
An observational study of Depression, run by Vastra Gotaland Region at 3 sites in Sweden.
Trial summary
Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- iTBS (intermittent theta-burst stimulation)
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Mar 2026to 1 Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for AiTBS treatment at participating study sites will be invited to participate in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Caroline Wass, +46 3039 8000, caroline.wass@vgregion.se
- Recruiting
Kungälv Hospital, Kungälv
Kungälv
Melker Hagsäter, +46 10441 00 00, melker.hagsater@vgregion.se
- Recruiting
Central Hospital Växjö
Vaxjo
Melker Hagsäter, +46 10441 00 00, melker.hagsater@vgregion.se
About this study
Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.
- Conditions
- Depression
- Being tested
- iTBS (intermittent theta-burst stimulation)
- Keywords
- iTBS, rTMS, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS (intermittent theta-burst stimulation)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 1W-AiTBS | Magnetic pulses of 80% 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 a maximum of 8 sessions per day (>15 min interval), total of 30 treatments on total of 10 week days. Receives: Device: iTBS (intermittent theta-burst stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in MADRS-S from baseline to six weeks after first iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Measured: 6 weeks
Secondary outcomes (18)
Difference in MADRS-S from baseline to after last iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Measured: 2 weeks
Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Measured: 12 weeks
Difference in MADRS-S from baseline to six months after first iTBS treatment
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
Measured: 6 months
Difference in SDS from baseline to twelve weeks after first iTBS treatment
The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment
Measured: 12 weeks
Difference in SDS from baseline to six months after first iTBS treatment
The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment
Measured: 6 months
Difference in EQ-VAS from baseline to after last iTBS treatment
The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life
Measured: 2 weeks
Difference in EQ-VAS from baseline to six weeks after first iTBS treatment
The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life
Measured: 6 weeks
Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment
The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life
Measured: 12 weeks
Difference in EQ-VAS from baseline to six months after first iTBS treatment
The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life
Measured: 6 months
Difference in reported potential side effects from baseline to after last iTBS treatment
A patient-reported form including the most commonly reported side effects of rTMS.
Measured: 2 weeks
Difference in reported potential side effects from baseline to six weeks after first iTBS treatment
A patient-reported form including the most commonly reported side effects of rTMS.
Measured: 6 weeks
Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment
A patient-reported form including the most commonly reported side effects of rTMS.
Measured: 12 weeks
Difference in reported potential side effects from baseline to six months after first iTBS treatment
A patient-reported form including the most commonly reported side effects of rTMS.
Measured: 6 months
rTMS associated pain experience
A patient-reported form rating experience of pain (scale 1 to 10) during rTMS treatment. Performed after last treatment series
Measured: 2 weeks
Number of patients in remission after last iTBS treatment
A patient with a MADRS-S score of < 10 is considered to be in remission
Measured: 2 weeks
Number of patients in remission six weeks after first iTBS treatment
A patient with a MADRS-S score of < 10 is considered to be in remission
Measured: 6 weeks
Number of patients in remission twelve weeks after first iTBS treatment
A patient with a MADRS-S score of < 10 is considered to be in remission
Measured: 12 weeks
Number of patients in remission six months after first iTBS treatment
A patient with a MADRS-S score of < 10 is considered to be in remission
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449338
- Sponsor's protocol ID
- 1W-AiTBS
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
- ClinicalTrials.gov ID
- NCT07449338
- Acronym / sponsor ID
- 1W-AiTBS
- Conditions
- Depression
- Keywords
- iTBS, rTMS, depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1W-AiTBS | – | Device: iTBS (intermittent theta-burst stimulation)Magnetic pulses of 80% 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 a maximum of 8 sessions per day (>15 min interval), total of 30 treatments on total of 10 week days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for AiTBS treatment at participating study sites will be invited to participate in the study.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 1W-AiTBS |
Primary outcome
Difference in MADRS-S from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
18 secondary outcomes
Difference in MADRS-S from baseline to after last iTBS treatment
Time frame: 2 weeks
Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment
Time frame: 12 weeks
Difference in MADRS-S from baseline to six months after first iTBS treatment
Time frame: 6 months
Difference in SDS from baseline to twelve weeks after first iTBS treatment
Time frame: 12 weeks
Difference in SDS from baseline to six months after first iTBS treatment
Time frame: 6 months
Difference in EQ-VAS from baseline to after last iTBS treatment
Time frame: 2 weeks
Difference in EQ-VAS from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment
Time frame: 12 weeks
Difference in EQ-VAS from baseline to six months after first iTBS treatment
Time frame: 6 months
Difference in reported potential side effects from baseline to after last iTBS treatment
Time frame: 2 weeks
Difference in reported potential side effects from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment
Time frame: 12 weeks
Difference in reported potential side effects from baseline to six months after first iTBS treatment
Time frame: 6 months
rTMS associated pain experience
Time frame: 2 weeks
Number of patients in remission after last iTBS treatment
Time frame: 2 weeks
Number of patients in remission six weeks after first iTBS treatment
Time frame: 6 weeks
Number of patients in remission twelve weeks after first iTBS treatment
Time frame: 12 weeks
Number of patients in remission six months after first iTBS treatment
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Vastra Gotaland Region at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melker Hagsäter, MD, MSc, PhD, PhD (+46 3039 8000, melker.hagsater@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in MADRS-S from baseline to six weeks after first iTBS treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.