A Brain-Stimulation showdown: can accelerated therapy outpace standard care for depression?

NCT ID NCT05900271

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

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.

Depressive Disorder, Treatment-Resistant

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Amsterdam UMC location AMC

    RECRUITING

    Amsterdam-Zuidoost, North Holland, 1105AZ, Netherlands

  • GGZinGeest

    RECRUITING

    Amsterdam, North Holland, 1081JC, Netherlands

  • Maastricht UMC

    NOT_YET_RECRUITING

    Maastricht, Netherlands

  • Radboud UMC

    RECRUITING

    Nijmegen, GL, 6525GA, Netherlands

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