Magnetic pulses to the brain: a new hope for depression?
NCT ID NCT04392947
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested whether a type of brain stimulation called theta burst stimulation (TBS) can help people with major depression who haven't gotten enough relief from standard treatments. 238 adults with moderate to severe depression received either real TBS or a sham (fake) version daily for 6 weeks, alongside their usual care. The goal was to see if TBS could reduce depression scores by at least half.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcranial Magnetic Stimulation (TMS) – theta burst stimulation
- What this could lead to
- If it works, this could offer a non-drug add-on treatment to ease depression symptoms for people who haven't responded well to antidepressants.
- What could go wrong
- This is a completed trial, but results are not yet published. The effect may be small or no better than sham, and it requires daily clinic visits for 6 weeks.
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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238 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Jul 2025
- 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 70 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: * moderate or severe unipolar depression diagnosed according to criteria of Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) * duration of the current episode must be ≥ 6 weeks and ≤ 2 years * HDRS17 ≥ 18 * mild to moderate treatment resistance according to the Antidepressant Treatment History Form \[ATHF-SF\]. Treatment resistance is defined as having failed at least one but no more than three adequate antidepressant treatments in this episode * stable antidepressive medication 4 weeks before treatment or no antidepressive treatment * no further relevant psychiatric axis-I and/or axis-II disorder except for anxiety disorders (according to DSM-5 and SCID-5-PD) * no comorbid psychotic symptoms * ability to give consent Exclusion Criteria: * acute suicidality (MADRS item 10 score \> 4) * antiepileptic drugs and/or benzodiazepines corresponding to \> 1mg lorazepam / day * history of brain surgery, significant and clinically relevant brain malformation or neoplasm, head injury, stroke, dementia or other neurodegenerative disorder * history of seizures * previous rTMS treatment * lifetime history of non-response to adequate electroconvulsive therapy (minimum of eight treatments) * deep brain stimulation * cardiac pacemakers, intracranial implant, or metal in the cranium * substance dependence or abuse in the past 3 months (with the exception of tobacco) * severe somatic comorbidity as judged by the study physician * 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.
Contacts and locations
Locations
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Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, University of Augsburg, Bezirkskrankenhaus Augsburg
Augsburg, 86156, Germany
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University of Leipzig, Dept. Psychiatry and Psychotherapy
Leipzig, Germany
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University of Munich
Munich, 80336, Germany
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University of Regensburg, Dept. Psychiatry and Psychotherapy
Regensburg, 93053, Germany
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University of Tuebingen, Dept Psychiatry and Psychotherapy
Tübingen, 72076, Germany
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University of Um, Dept. Psychiatry and Psychotherapy
Ulm, 89075, Germany
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University of Wuerzburg, Dept. Psychiatry and Psychotherapy
Würzburg, Germany
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