Depression - Major Depressive DisorderPhase 4NCT07026461
Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression
A Phase 4 study testing repetitive transcranial magnetic stimulation and intermittent theta burst stimulation in people with Depression - Major Depressive Disorder and Depression Bipolar, run by Region Örebro County at 2 sites in Sweden.
Trial summary
Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression. Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression - Major Depressive Disorder, Depression Bipolar
- What is being tested?
- repetitive transcranial magnetic stimulation and intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Dec 2025to 31 Dec 2031
- Phase
- Phase 4
- 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
- At least 18 years of age at the time of inclusion.
- A clinical diagnosis of unipolar or bipolar depression according to ICD-10.
- Acceptance of rTMS.
- A Swedish personal identity number.
- Capable of giving informed consent.
Who cannot join
- If the investigator judges one of the two treatment protocols inappropriate for the patient.
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
Unit for Brainstimulation
Örebro
- Recruiting
Unit for Brainstimulation
Uppsala
Robert Bodén, MD, PhD, +46186110000, robert.boden@uu.se
Robert Bodén, MD,PhD
About this study
Official title: Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial
Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.
Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.
Read more
Primary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.
Secondary objectives: Include testing for differences in:
- Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI).
- Response to treatment (a decrease of 50% on MADRS-S)
- Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS).
- Drop-out from treatment.
- Stimulation site pain measured with the Numerical Rating Scales (NRS).
- Adverse events.
- Admission and suicides within 6 months.
- New treatment course of rTMS or ECT within 6 months
- Remission (score < 11 on the MADRS-S)
- Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS).
Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients.
Inclusion criteria:
- At least 18 years of age at the time of inclusion.
- A clinical diagnosis of unipolar or bipolar depression according to ICD-10.
- Acceptance of rTMS.
- A Swedish personal identity number.
- Capable of giving informed consent.
Exclusion criteria:
- If the investigator judges one of the two treatment protocols inappropriate for the patient.
Inclusion time: 2025-07-01 to 2029-01-01
- Being tested
- repetitive transcranial magnetic stimulation, intermittent theta burst stimulation
- Keywords
- rtms, itbs, repetitive transcranial magnetic stimulation, randomized controlled trial, intermittent theta-burst stimulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Also called rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses pulsed magnetic fields to activate or suppress specific brain regions. It is used to treat various conditions, including major depressive disorder, by inducing small electrical currents that stimulate nerve cells.
intermittent theta burst stimulationDevice
Intermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation (TMS) used to modulate brain activity. It involves delivering brief bursts of magnetic pulses to specific brain regions, typically the left dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| right-sided rTMS | Experimental | right-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation Receives: Device: repetitive transcranial magnetic stimulation |
| left-sided iTBS | Active comparator | left-sided intermittent theta burst stimulation Receives: Device: intermittent theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the MADRS-S score
reduction in the MADRS-S score from baseline to the end of treatment
Measured: 6 weeks
Secondary outcomes (10)
Stimulation site pain
Stimulation site pain (self-rated by patients using Numerical Rating Scales (NRS)).
Measured: 15 minutes
CGI-I
Professionally determined response according to Clinical Global Impression Scale-Improvement (CGI-I)
Measured: 6 weeks
Patient rate remission
Remission (score < 11 on the MADRS-S)
Measured: 6 weeks
Patient rated response
Response to treatment (a decrease of 50% on MADRS-S)
Measured: 6 weeks
Self-rated EQ-5D-VAS
Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS)
Measured: 6 weeks
Drop-out
Drop-out from treatment for any reason within 30 sessions
Measured: 6 weeks
Adverse events
Adverse events including severe adverse events
Measured: 6 weeks, follow-up at 6 months
Self-rated EQ-5D-VAS at 6-month follow-up
Self-rated global health measured with the EQ-5D-VAS at 6-month follow-up
Measured: 6 months
Self rated remission at 6-month follow-up
Self rated remission (score < 11 on MADRS-S) at 6-month follow-up
Measured: 6 months
Hospital admission
Hospital admissions for depression, hypomanic/manic switch, suicide attempts, and deaths including completed suicides within 6 months after randomization
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 posted18 Jun 2025
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Axel Nordenskjöld, MD, PhD, Study chair, Region Örebro County, Örebro UniversityRobert Bodén, MD, PhD, Principal investigator, Uppsala University, Region Uppsala County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07026461
- Sponsor's protocol ID
- 3.1
- Other IDs
- CIV-ID 23-06-043272
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available from the corresponding author upon reasonabe request
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07026461
- Acronym / sponsor ID
- 3.1
- Keywords
- rtms, itbs, repetitive transcranial magnetic stimulation, randomized controlled trial, intermittent theta-burst stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 18 Jun 2025 (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.
Aim: The purpose of the study is to establish the non-inferiority of right-sided inhibitory 1 Hz stimulation compared to left-sided intermittent theta burst stimulation (iTBS) in unipolar and bipolar depression.
Design: A national, non-inferiority, register-based, randomized trial, unmasked, with two treatment arms.
Primary objective: The primary objective is to determine if right-sided inhibitory 1-Hz stimulation to dorsolateral prefrontal cortex (DLPFC) is non inferior to iTBS in treating unipolar and bipolar depression by measuring reduction in Montgomery-Åsberg Depression Rating Scale, self-assessed version (MADRS-S) from baseline to end of treatment.
Secondary objectives: Include testing for differences in:
- Observer rated response according to Clinical Global Impression Scale-Improvement (≥2 point reduction CGI).
- Response to treatment (a decrease of 50% on MADRS-S)
- Self-rated global health measured with the EuroQual-group 5 Dimensions Scale Visual Analogue Scale (EQ-5D-VAS).
- Drop-out from treatment.
- Stimulation site pain measured with the Numerical Rating Scales (NRS).
- Adverse events.
- Admission and suicides within 6 months.
- New treatment course of rTMS or ECT within 6 months
- Remission (score < 11 on the MADRS-S)
- Memory impairment measured with the Comprehensive Psychopathological Rating Scale (CPRS).
Study population: Patients with unipolar or bipolar depression. Sample size: 350 patients.
Inclusion criteria:
- At least 18 years of age at the time of inclusion.
- A clinical diagnosis of unipolar or bipolar depression according to ICD-10.
- Acceptance of rTMS.
- A Swedish personal identity number.
- Capable of giving informed consent.
Exclusion criteria:
- If the investigator judges one of the two treatment protocols inappropriate for the patient.
Inclusion time: 2025-07-01 to 2029-01-01
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right-sided rTMS | Experimental | Device: repetitive transcranial magnetic stimulationright-sided inhibitory 1 Hz repetitive transcranial magnetic stimulation |
| left-sided iTBS | Active comparator | Device: intermittent theta burst stimulationleft-sided intermittent theta burst stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age at the time of inclusion.
- A clinical diagnosis of unipolar or bipolar depression according to ICD-10.
- Acceptance of rTMS.
- A Swedish personal identity number.
- Capable of giving informed consent.
Key exclusion criteria (1 listed)
- If the investigator judges one of the two treatment protocols inappropriate for the patient.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationAlso: rTMSRepetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique that uses pulsed magnetic fields to activate or suppress specific brain regions. It is used to treat various conditions, including major depressive disorder, by inducing small electrical currents that stimulate nerve cells. | Device | right-sided rTMS |
| intermittent theta burst stimulationIntermittent theta-burst stimulation (iTBS) is a form of transcranial magnetic stimulation (TMS) used to modulate brain activity. It involves delivering brief bursts of magnetic pulses to specific brain regions, typically the left dorsolateral prefrontal cortex (DLPFC) | Device | left-sided iTBS |
Primary outcome
reduction in the MADRS-S score
Time frame: 6 weeks
reduction in the MADRS-S score from baseline to the end of treatment
10 secondary outcomes
Stimulation site pain
Time frame: 15 minutes
CGI-I
Time frame: 6 weeks
Patient rate remission
Time frame: 6 weeks
Patient rated response
Time frame: 6 weeks
Self-rated EQ-5D-VAS
Time frame: 6 weeks
Drop-out
Time frame: 6 weeks
Adverse events
Time frame: 6 weeks, follow-up at 6 months
Self-rated EQ-5D-VAS at 6-month follow-up
Time frame: 6 months
Self rated remission at 6-month follow-up
Time frame: 6 months
Hospital admission
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 16 Dec 2025.
- Individual participant dataSharing planned: No. Data will be available from the corresponding author upon reasonabe request
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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.
Axel Nordenskjöld, MD, PhD study chair
Region Örebro County, Örebro University
Robert Bodén, MD, PhD principal investigator
Uppsala University, Region Uppsala County
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing repetitive transcranial magnetic stimulation and intermittent theta burst stimulation in people with Depression - Major Depressive Disorder and Depression Bipolar, run by Region Örebro County 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 5 inclusion and 1 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 16 Dec 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Axel Nordenskjöld, MD,PhD (+46196021000, axel.nordenskjold@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the MADRS-S score (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 16 Dec 2025.