DepressionVAiTNCT06138678
VGR Accelerated TMS Treatment for Depression
A study testing iTBS (intermittent theta-burst stimulation) in people with Depression, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
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. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Jan 2024to 1 Aug 2027
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- intracardiac lines, even when removed
- regular use of benzodiazepines
- any condition that seriously increases the risk of non-compliance or loss of follow-up
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Kungälv Hospital
Kungälv
Melker Hagsäter, +46 10441 00 00, melker.hagsater@vgregion.se
- Recruiting
Hospital of Skövde
Skövde
About this study
Official title: Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression
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
- 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 |
|---|---|---|
| Accelerated iTBS protocol | Experimental | 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. Receives: Device: iTBS (intermittent theta-burst stimulation) |
| Routine iTBS protocol | Active comparator | 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. 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 three 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: 3 weeks
Secondary outcomes (24)
Difference in MADRS-S from baseline to one week 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: 1 week
Difference in MADRS-S from baseline to two 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: 2 weeks
Difference in MADRS-S from baseline to four 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: 4 weeks
Difference in MADRS-S from baseline to five 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: 5 weeks
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
Difference in MADRS-S from baseline to six months 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: 6 months
Difference in QIDS-SR from baseline to one week after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 1 week
Difference in QIDS-SR from baseline to two weeks after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 2 weeks
Difference in QIDS-SR from baseline to three weeks after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 3 weeks
Difference in QIDS-SR from baseline to four weeks after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 4 weeks
Difference in QIDS-SR from baseline to five weeks after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 5 weeks
Difference in QIDS-SR from baseline to six weeks after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 6 weeks
Difference in QIDS-SR from baseline to six months after first iTBS treatment
The self-rating Quick Inventory of Depressive Symptomatology (QIDS-SR) is a rating scale (0-27 points), where a higher score indicates worse depressive symptoms
Measured: 6 months
Difference in SDS from baseline to six 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: 6 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 three 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: 3 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 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 CGI-S from baseline to three weeks after first iTBS treatment
The Clinical Global Impression - Severity scale (CGI-S) is a clinical rating scale (0-7 points), where a higher score indicates more severe symptoms
Measured: 3 weeks
Difference in CGI-S from baseline to six weeks after first iTBS treatment
The Clinical Global Impression - Severity scale (CGI-S) is a clinical rating scale (0-7 points), where a higher score indicates more severe symptoms
Measured: 6 weeks
Difference in CGI-I from baseline to three weeks after first iTBS treatment
The Clinical Global Impression - Improvement scale (CGI-I) is a clinical rating scale (0-7 points) of symptom improvement (lower score)/worsening (higher score) compared to baseline
Measured: 3 weeks
Difference in CGI-I from baseline to six weeks after first iTBS treatment
The Clinical Global Impression - Improvement scale (CGI-I) is a clinical rating scale (0-7 points) of symptom improvement (lower score)/worsening (higher score) compared to baseline
Measured: 6 weeks
Number of patients in remission three weeks after first iTBS treatment
A patient with a MADRS-S score of < 10 is considered to be in remission
Measured: 3 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Aug 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University, Uppsala University, The Swedish Society of Medicine
- Responsible party
- Sponsor
- Investigators
- Melker Hagsäter, MD, MSc, PhD, Principal investigator, Västra Götaland Regional Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138678
- Sponsor's protocol ID
- VAiT
- Acronym
- VAiT
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vastra Gotaland Region Accelerated Transcranial Magnetic Stimulation Treatment for Depression
- ClinicalTrials.gov ID
- NCT06138678
- Acronym / sponsor ID
- VAiT / VAiT
- Conditions
- Depression
- Keywords
- iTBS, rTMS, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University, Uppsala University, The Swedish Society of Medicine
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Nov 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS protocol | Experimental | Device: iTBS (intermittent theta-burst stimulation)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. |
| Routine iTBS protocol | Active comparator | Device: iTBS (intermittent theta-burst stimulation)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 | Accelerated iTBS protocol, Routine iTBS protocol |
Primary outcome
Difference in MADRS-S from baseline to three weeks after first iTBS treatment
Time frame: 3 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
24 secondary outcomes
Difference in MADRS-S from baseline to one week after first iTBS treatment
Time frame: 1 week
Difference in MADRS-S from baseline to two weeks after first iTBS treatment
Time frame: 2 weeks
Difference in MADRS-S from baseline to four weeks after first iTBS treatment
Time frame: 4 weeks
Difference in MADRS-S from baseline to five weeks after first iTBS treatment
Time frame: 5 weeks
Difference in MADRS-S from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Difference in MADRS-S from baseline to six months after last iTBS treatment
Time frame: 6 months
Difference in QIDS-SR from baseline to one week after first iTBS treatment
Time frame: 1 week
Difference in QIDS-SR from baseline to two weeks after first iTBS treatment
Time frame: 2 weeks
Difference in QIDS-SR from baseline to three weeks after first iTBS treatment
Time frame: 3 weeks
Difference in QIDS-SR from baseline to four weeks after first iTBS treatment
Time frame: 4 weeks
Difference in QIDS-SR from baseline to five weeks after first iTBS treatment
Time frame: 5 weeks
Difference in QIDS-SR from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Difference in QIDS-SR from baseline to six months after first iTBS treatment
Time frame: 6 months
Difference in SDS from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Difference in SDS from baseline to six months after first iTBS treatment
Time frame: 6 months
Difference in EQ-VAS from baseline to three weeks after first iTBS treatment
Time frame: 3 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 six months after first iTBS treatment
Time frame: 6 months
Difference in CGI-S from baseline to three weeks after first iTBS treatment
Time frame: 3 weeks
Difference in CGI-S from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Difference in CGI-I from baseline to three weeks after first iTBS treatment
Time frame: 3 weeks
Difference in CGI-I from baseline to six weeks after first iTBS treatment
Time frame: 6 weeks
Number of patients in remission three weeks after first iTBS treatment
Time frame: 3 weeks
Number of patients in remission six weeks after first iTBS treatment
Time frame: 6 weeks
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 25 Nov 2024.
- 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.
Melker Hagsäter, MD, MSc, PhD principal investigator
Västra Götaland Regional Council
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS (intermittent theta-burst stimulation) in people with Depression, run by Vastra Gotaland Region at 2 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 8 inclusion and 9 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 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 (+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 three weeks after first iTBS treatment (time frame: 3 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 25 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.