A Brain-Stimulation showdown: can accelerated therapy outpace standard care for depression?
NCT ID NCT05900271
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial tests whether an accelerated, precisely targeted brain-stimulation protocol can outperform the standard approach for people with treatment-resistant depression. Participants receive either the new accelerated intermittent theta burst stimulation (iTBS) or the standard 10 Hz repetitive transcranial magnetic stimulation (rTMS). The study compares how many people achieve remission, as well as cost-effectiveness, quality of life, and safety over a 25-week follow-up.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A brain-stimulation device delivering either accelerated intermittent theta burst stimulation (iTBS) or standard 10 Hz repetitive transcranial magnetic stimulation (rTMS)
- What this could lead to
- If the accelerated protocol works better, it could offer a faster, more effective treatment option for people with depression that hasn't improved with standard therapies.
- What could go wrong
- The trial is relatively small and early, and the accelerated protocol may not prove more effective or cost-effective than standard treatment. Brain stimulation can cause side effects like headache or discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * \- 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC location AMC
RECRUITINGAmsterdam-Zuidoost, North Holland, 1105AZ, Netherlands
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GGZinGeest
RECRUITINGAmsterdam, North Holland, 1081JC, Netherlands
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Maastricht UMC
NOT_YET_RECRUITINGMaastricht, Netherlands
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Radboud UMC
RECRUITINGNijmegen, GL, 6525GA, Netherlands
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- Neural and antidepressant effects of propofol
- Can pairing ketamine with talk therapy beat depression alone?
- Can a psychedelic drug lift depression that won't budge?
- Can a 6,000-Person study unlock personalized depression care for asians?
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