Treatment Resistant DepressionDDOTTNCT05900271
Dutch-Depression Outcome Trial Comparing 5 Day Multi Daily Neuronavigated Theta Burst Sessions With 6 Weeks rTMS
A study testing rTMS and iTBS in people with Treatment Resistant Depression, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.
Trial summary
INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol, contribute to extreme high overall remission of 79% in patients with treatment resistant depression… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- rTMS and iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 4 sitesNetherlands
- Study dates
- 15 Nov 2023to Dec 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Sufficient level of spoken and written Dutch;
- Ability to freely provide written informed consent;
- Current DSM-5 diagnosis of a depressive episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-S).
- A Hamilton depression rating score (HDRS) of >16 points: this score will be obtained from the SIGH-ADS, a depression rating scale able to determine the HDRS score and a score for atypical depression.
- have a treatment resistant depression, defined according to the criteria of Conway, that is, lack of remission for eight consecutive weeks after two different evidence-based treatments anti-depressant medication has to be adequately dosed(7,24).
- Stable anti-depressant medication 6 weeks prior to study. Benzodiazepines may be used up to a dosage equivalent of 3.0 mg lorazepam, and can be lowered over time during the study based on clinical judgement.
Who cannot join
- - Bipolar disorder.
- Current psychotic disorder¸ including psychotic depression, assessed by treating psychiatrist.
- Suspected dementia, assessed with a dementia screening tool, i.e., the Montreal Cognitive Assessment (MOCA)(25), with a score of less than 20 points, or a clinical suspicion of dementia, or neuroimaging indication for neurodegeneration with a Fazekas > 1 and MTA >1. These cut-offs ensure exclusion of patients with (preclinical) dementia.
- Active suicidal thoughts and intent to act on it, assessed at the baseline interview and before the start of the trial. This assessment is based on the Columbia suicide severity rating scale, i.e., question 5 is answered positive "Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?" (26).
- Metallic devices implanted above the neck, assessed at the baseline interview.
- Patients diagnosed with epilepsy, by a neurologist, assessed at the baseline interview.
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- Substance abuse 4 weeks prior to the study, including high dosage of benzodiazepine, a dosage equivalent higher than 3.0 mg lorazepam, assessed at the baseline interview.
- Inability to understand or comply with study requirements as judged by the investigators, assessed at the baseline interview.
- Pregnancy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Recruiting
GGZinGeest
Amsterdam, North Holland, 1081JC
Eric van Exel, +31204444444, e.vexel@amsterdamumc.nl
- Recruiting
Amsterdam UMC location AMC
Amsterdam-Zuidoost, North Holland, 1105AZ
Karel Scheepstra, +31205669111, k.scheepstra@amsterdamumc.nl
- Not yet recruiting
Maastricht UMC
Maastricht
Bart Rutten, bart.rutten@mumc.nl
- Recruiting
Radboud UMC
Nijmegen, GL, 6525GA
Philip van Eijndhoven, philip.vaneijndhoven@radboudumc.nl
About this study
Official title: Higher, Faster, Better: Is an Accelerated Intermittent Theta Burst Stimulation Protocol Compared to Standard 10 Hz Repetitive Transcranial Magnetic Stimulation, More (Cost-) Effective in Patients With Treatment-resistant Depression?
INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol, contribute to extreme high overall remission of 79% in patients with treatment resistant depression (TRD), whereas remission using a standard 10 Hz rTMS protocol is 25%. The improvement using the SNT protocol is achieved by combining 1) accelerated treatment with multiple sessions per day, 2) applying a higher overall pulse dose of stimulation, using intermittent Theta Burst Stimulation (iTBS), and 3) precise targeting of the region in the left dorsolateral prefrontal cortex (DLPFC), using functional MRI guided neuronavigation.
OBJECTIVE To determine if the SNT protocol is more (cost-) effective compared to standard 10 Hz rTMS in patients with TRD, even though the number of pulses given in both protocols is equal, i.e., 90,000.
Read more
STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks.
STUDY POPULATION 108 Patients with TRD (no response to 2 or more evidence-based treatments).
INTERVENTION 50 sessions using the SNT protocol in 5 days. The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI.
COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the left DLPFC based on standard measurement procedures of the skull.
OUTCOME MEASURES
- Remission, based on the Hamilton depression rating scale
- Cost effectiveness, based on healthcare resource use
- Quality of life and positive mental health
- Tolerability and safety
- Relapse
- Description of opportunities and difficulties with regard to implementation
SAMPLE SIZE The investigators will enrol 108 patients (α=0.05, power is 0.80) including adjustment for attrition.
COST EFFECTIVENESS ANALYSIS SNT is faster and possibly more effective than 10Hz rTMS leading to a total cost reduction of 22 million each year considering less expensive healthcare, reduced illness duration and absence from work.
TIME SCHEDULE Within 36 months, the investigators will recruit and treat 108 patients with TRD: each center will recruit 9 patients per year. After the last follow-up assessments, the investigators will finalise the study within 12 months and report the results.
Read the detailed description
Rationale: Novel therapies are crucial for patients with unipolar depression since more than 33% of these patients are medication-resistant. As a consequence, there is a high burden of illness for patients with depression, leading to increased suicide rates, inability to maintain proper work and/or social role functions, and reduced quality of life. A promising novel treatment strategy is an intensive five-day course of intermittent Theta Burst Stimulation (iTBS), a form of transcranial magnetic stimulation (rTMS), which could lead to exceptionally high remission rates (79%) in patients with treatment resistant depression. However, it remains unclear whether this novel treatment strategy is more effective in depressed patients when compared to standard 10Hz rTMS (remission 30%).
Hypothesis: 5-day multi daily neuronavigated iTBS sessions (developed by Stanford University and coined, SNT, i.e., Stanford NeuromdulaTion protocol) are more (cost-) effective than standard 10 Hz rTMS in patients with treatment resistant depression.
Objective: To determine remission of depression and cost effectiveness using the SNT protocol, in patients with treatment resistant depression who did not respond to two or more evidence-based treatments.
Study design: This study comprises a multicentre, two-phase, randomized clinical trial. Phase 1 comprises a randomized controlled trial. In Phase 1, participants will be assigned to one of the two active treatment conditions, and will receive either treatment using the SNT protocol (5 days of 10 sessions/day, resulting in 50 sessions in total 90000 pulses) or standard 10 Hz left sided rTMS, provided once daily during 6 weeks (30 sessions in total, 90000 pulses). Phase 2 comprises three follow-up measurements, one at 5 weeks, one at 10 weeks and one at 25 weeks after the last treatment with SNT or 10 Hz standard rTMS. Finally, participants who were allocated to standard 10 Hz rTMS will be offered SNT after the end of the study (e.g., 25 weeks after the last rTMS session). Patients allocated to SNT can obtain 10 Hz standard rTMS after SNT has been completed.
Study population: Adult patients with unipolar depression who did not respond to two or more evidence-based treatments for depression, in the current depressive episode, aged 18 years and over.
Sample size: Sample size calculations based on differences in remission suggest that a well-powered trial should consist of 108 patients (for a 2-sided test at alpha=0.05 and with power=0.80).
Intervention: 50 sessions using the SNT protocol in 5 days. The subregion of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex (sgACC) in each participant will be targeted based on patient-specific functional resting state magnetic resonance imaging .
Comparison: 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the left DLPFC based on standard scalp-based measurement procedures.
- Conditions
- Treatment Resistant Depression
- Being tested
- rTMS, iTBS
- Keywords
- TMS, treatment resistant depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
10 Hz repetitive-transcranial-magnetic-stimulation
iTBSDevice
neuronavigated intermittent theta burst transcranial-magnetic-stimulation
| Study group | Role | What they receive |
|---|---|---|
| intermittent theta burst transcranial magnetic stimulation (iTBS) | Experimental | 5-day multi daily neuronavigated intermittent theta burst sessions (developed by Stanford University) and coined, SNT, i.e., Stanford NeuromdulaTion protocol Receives: Device: iTBS |
| 10 Hz repetitive-transcranial-magnetic-stimulation (rTMS) | Active comparator | 6-weeks standard 10 Hz rTMS Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
Clinical outcome is remission, which is defined as a score of 7 or lower on the clinician-rated HDRS-17 (17-itemHamilton Depression Rating Scale, scores 0-52 with higher score indicating worse outcome) measured one week after the last treatment session.
Measured: After 1 week.
Secondary outcomes (5)
Health-related quality of life
Health-related quality of life determined with the EQ 5D-5L (EuroQol 5 Dimension 5 Level, scores 5-25, with higher scores indicating worse outcome).
Measured: After 1-, 5-, 10- and 25-weeks.
Self-rated depressive symptoms
Percentual reduction of depressive symptoms as measured with self-rated HDRS-6 (self-rated 6-item Hamilton Depression Rating Scale, scores 0-18 with higher score indicating worse outcome).
Measured: After 1-, 5-, 10- and 25-weeks.
Relapse
Relapse, at 5-, 10- and 25-weeks post-treatment. Relapse is defined as a HDRS-17 (17-item Hamilton Depression Rating Scale, scores 0-52 with higher score indicating worse outcome) total score of 15 or higher for 2 consecutive assessments separated by 5 to 15 days or hospitalization for depression
Measured: After1-, 5-, 10- and 25-weeks.
Side-effects
Establish tolerability of the treatment and side effects, of SNT and rTMS.
Measured: After 1- and 6- weeks.
Remission
Clinical outcome is remission, which is defined as a score of 7 or lower on the clinician-rated HDRS-17 (17-item Hamilton Depression Rating Scale, scores 0-52 with higher score indicating worse outcome) measured directly after the last treatment session.
Measured: 5-, 10- and 25-weeks after the last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Nov 2023
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre, two-phase, randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Maastricht University Medical Center, Maastricht University, Trimbos, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Donders Centre for Neuroscience
- Responsible party
- Principal investigator, Annemiek Dols, MD, PhD, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900271
- Sponsor's protocol ID
- 10390012110079
- Acronym
- DDOTT
- Status last verified
- Aug 2026
- First submitted
- 10 May 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dols A, Biemans T, Coomans C, van Eijndhoven P, Dalhuisen I, van der Werf YD, Vriend C, Gomes ESA, Sack AT, Schuhmann T, Chaudhry M, Arns M, Walters BH, Wijnen B, Zalesky A, Cash R, Blumberger DM, Scheepstra KW, Hoogendoorn AW, van den Heuvel OA, van Exel E; D-DOTT Consortium. Comparison of 5-Day Multidaily Neuronavigated Theta-Burst Sessions With 6-Week Standard Repetitive Transcranial Magnetic Stimulation (the Dutch Depression Outcome Trial): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 21;14:e70121. doi: 10.2196/70121.
PubMed 40840870
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher, Faster, Better: Is an Accelerated Intermittent Theta Burst Stimulation Protocol Compared to Standard 10 Hz Repetitive Transcranial Magnetic Stimulation, More (Cost-) Effective in Patients With Treatment-resistant Depression?
- ClinicalTrials.gov ID
- NCT05900271
- Acronym / sponsor ID
- DDOTT / 10390012110079
- Conditions
- Treatment Resistant Depression
- Keywords
- TMS, treatment resistant depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Maastricht University Medical Center, Maastricht University, Trimbos, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Donders Centre for Neuroscience
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jun 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.
INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol, contribute to extreme high overall remission of 79% in patients with treatment resistant depression (TRD), whereas remission using a standard 10 Hz rTMS protocol is 25%. The improvement using the SNT protocol is achieved by combining 1) accelerated treatment with multiple sessions per day, 2) applying a higher overall pulse dose of stimulation, using intermittent Theta Burst Stimulation (iTBS), and 3) precise targeting of the region in the left dorsolateral prefrontal cortex (DLPFC), using functional MRI guided neuronavigation.
OBJECTIVE To determine if the SNT protocol is more (cost-) effective compared to standard 10 Hz rTMS in patients with TRD, even though the number of pulses given in both protocols is equal, i.e., 90,000.
STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks.
STUDY POPULATION 108 Patients with TRD (no response to 2 or more evidence-based treatments).
INTERVENTION 50 sessions using the SNT protocol in 5 days. The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI.
COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the left DLPFC based on standard measurement procedures of the skull.
OUTCOME MEASURES
- Remission, based on the Hamilton depression rating scale
- Cost effectiveness, based on healthcare resource use
- Quality of life and positive mental health
- Tolerability and safety
- Relapse
- Description of opportunities and difficulties with regard to implementation
SAMPLE SIZE The investigators will enrol 108 patients (α=0.05, power is 0.80) including adjustment for attrition.
COST EFFECTIVENESS ANALYSIS SNT is faster and possibly more effective than 10Hz rTMS leading to a total cost reduction of 22 million each year considering less expensive healthcare, reduced illness duration and absence from work.
TIME SCHEDULE Within 36 months, the investigators will recruit and treat 108 patients with TRD: each center will recruit 9 patients per year. After the last follow-up assessments, the investigators will finalise the study within 12 months and report the results.
Detailed description
Rationale: Novel therapies are crucial for patients with unipolar depression since more than 33% of these patients are medication-resistant. As a consequence, there is a high burden of illness for patients with depression, leading to increased suicide rates, inability to maintain proper work and/or social role functions, and reduced quality of life. A promising novel treatment strategy is an intensive five-day course of intermittent Theta Burst Stimulation (iTBS), a form of transcranial magnetic stimulation (rTMS), which could lead to exceptionally high remission rates (79%) in patients with treatment resistant depression. However, it remains unclear whether this novel treatment strategy is more effective in depressed patients when compared to standard 10Hz rTMS (remission 30%).
Hypothesis: 5-day multi daily neuronavigated iTBS sessions (developed by Stanford University and coined, SNT, i.e., Stanford NeuromdulaTion protocol) are more (cost-) effective than standard 10 Hz rTMS in patients with treatment resistant depression.
Objective: To determine remission of depression and cost effectiveness using the SNT protocol, in patients with treatment resistant depression who did not respond to two or more evidence-based treatments.
Study design: This study comprises a multicentre, two-phase, randomized clinical trial. Phase 1 comprises a randomized controlled trial. In Phase 1, participants will be assigned to one of the two active treatment conditions, and will receive either treatment using the SNT protocol (5 days of 10 sessions/day, resulting in 50 sessions in total 90000 pulses) or standard 10 Hz left sided rTMS, provided once daily during 6 weeks (30 sessions in total, 90000 pulses). Phase 2 comprises three follow-up measurements, one at 5 weeks, one at 10 weeks and one at 25 weeks after the last treatment with SNT or 10 Hz standard rTMS. Finally, participants who were allocated to standard 10 Hz rTMS will be offered SNT after the end of the study (e.g., 25 weeks after the last rTMS session). Patients allocated to SNT can obtain 10 Hz standard rTMS after SNT has been completed.
Study population: Adult patients with unipolar depression who did not respond to two or more evidence-based treatments for depression, in the current depressive episode, aged 18 years and over.
Sample size: Sample size calculations based on differences in remission suggest that a well-powered trial should consist of 108 patients (for a 2-sided test at alpha=0.05 and with power=0.80).
Intervention: 50 sessions using the SNT protocol in 5 days. The subregion of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex (sgACC) in each participant will be targeted based on patient-specific functional resting state magnetic resonance imaging .
Comparison: 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the left DLPFC based on standard scalp-based measurement procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- multicentre, two-phase, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| intermittent theta burst transcranial magnetic stimulation (iTBS) | Experimental | Device: iTBS5-day multi daily neuronavigated intermittent theta burst sessions (developed by Stanford University) and coined, SNT, i.e., Stanford NeuromdulaTion protocol |
| 10 Hz repetitive-transcranial-magnetic-stimulation (rTMS) | Active comparator | Device: rTMS6-weeks standard 10 Hz rTMS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older;
- Sufficient level of spoken and written Dutch;
- Ability to freely provide written informed consent;
- Current DSM-5 diagnosis of a depressive episode, ascertained by the Mini International Neuropsychiatry Interview (MINI-S).
- A Hamilton depression rating score (HDRS) of >16 points: this score will be obtained from the SIGH-ADS, a depression rating scale able to determine the HDRS score and a score for atypical depression.
Key exclusion criteria (9 listed)
- - Bipolar disorder.
- Current psychotic disorder¸ including psychotic depression, assessed by treating psychiatrist.
- Suspected dementia, assessed with a dementia screening tool, i.e., the Montreal Cognitive Assessment (MOCA)(25), with a score of less than 20 points, or a clinical suspicion of dementia, or neuroimaging indication for neurodegeneration with a Fazekas > 1 and MTA >1. These cut-offs ensure exclusion of patients with (preclinical) dementia.
- Active suicidal thoughts and intent to act on it, assessed at the baseline interview and before the start of the trial. This assessment is based on the Columbia suicide severity rating scale, i.e., question 5 is answered positive "Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?" (26).
- Metallic devices implanted above the neck, assessed at the baseline interview.
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 |
|---|---|---|
| rTMS10 Hz repetitive-transcranial-magnetic-stimulation | Device | 10 Hz repetitive-transcranial-magnetic-stimulation (rTMS) |
| iTBSneuronavigated intermittent theta burst transcranial-magnetic-stimulation | Device | intermittent theta burst transcranial magnetic stimulation (iTBS) |
Primary outcome
Remission
Time frame: After 1 week.
Clinical outcome is remission, which is defined as a score of 7 or lower on the clinician-rated HDRS-17 (17-itemHamilton Depression Rating Scale, scores 0-52 with higher score indicating worse outcome) measured one week after the last treatment session.
5 secondary outcomes
Health-related quality of life
Time frame: After 1-, 5-, 10- and 25-weeks.
Self-rated depressive symptoms
Time frame: After 1-, 5-, 10- and 25-weeks.
Relapse
Time frame: After1-, 5-, 10- and 25-weeks.
Side-effects
Time frame: After 1- and 6- weeks.
Remission
Time frame: 5-, 10- and 25-weeks after the last treatment session.
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 20 Aug 2026.
- Derived from this study: PubMed 40840870Dols A, Biemans T, Coomans C, van Eijndhoven P, Dalhuisen I, van der Werf YD, Vriend C, Gomes ESA, Sack AT, Schuhmann T, Chaudhry M, Arns M, Walters BH, Wijnen B, Zalesky A, Cash R, Blumberger DM, Scheepstra KW, Hoogendoorn AW, van den Heuvel OA, van Exel E; D-DOTT Consortium. Comparison of 5-Day Multidaily Neuronavigated Theta-Burst Sessions With 6-Week Standard Repetitive Transcranial Magnetic Stimulation (the Dutch Depression Outcome Trial): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 21;14:e70121. doi: 10.2196/70121.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS and iTBS in people with Treatment Resistant Depression, run by Amsterdam UMC, location VUmc at 4 sites in Netherlands.
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 7 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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 Annemiek Dols, MD PhD (0610445878, a.dols@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: After 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05900271, which also lists 1 linked publication.
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 20 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.