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Effectiveness of rTMS compared to SSRI as early treatment of depression – study protocol of a randomized controlled trial (Early-TMS).

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Title: Effectiveness of rTMS compared to SSRI as early treatment of depression – study protocol of a randomized controlled trial (Early-TMS).
Authors: Becker-Sadzio, Julia (AUTHOR), Brendel, Bettina (AUTHOR), Weller, Simone (AUTHOR), Bornheimer, Edmund (AUTHOR), Mehlig, Ulrike (AUTHOR), Padberg, Frank (AUTHOR), Vogelmann, Ulrike (AUTHOR), Kammer, Thomas (AUTHOR), Strube, Wolfgang (AUTHOR), Martus, Peter (AUTHOR), Fallgatter, Andreas J. (AUTHOR), Plewnia, Christian (AUTHOR)
Source: European Archives of Psychiatry & Clinical Neuroscience. Sep2025, Vol. 275 Issue 6, p1839-1849. 11p.
Subjects: Mental depression, Transcranial magnetic stimulation, Serotonin uptake inhibitors, Clinical trials, Randomized controlled trials, Treatment effectiveness
Abstract: Psychotherapy and antidepressant medication are considered first-line treatment options for major depressive disorder (MDD). However, a high proportion of patients do not respond to initial treatment, underlining the need for alternative treatment methods. Repetitive transcranial magnetic stimulation (rTMS) has been established in the treatment of MDD, but the available evidence is limited to forms of MDD with varying degrees of treatment resistance. Randomized-controlled trials (RCT) investigating first-line treatment with rTMS in comparison with first-line antidepressant medication are warranted to further position rTMS within current treatment algorithms for MDD. In this two-stage, therapy response-adapted, randomized multi-center phase 2 rater blinded trial, 106 medication-naïve patients suffering from MDD will be enrolled. In Stage I, participants receive one of the two treatment options for four weeks: either daily bilateral theta burst stimulation (TBS), a patterned and time-saving form of rTMS, or antidepressant medication with selective serotonin reuptake inhibitors (SSRI). The allocation to Stage II occurs therapy response-adapted. Therefore, patients either receive maintenance treatment or will be switched to the respective other treatment arm. Primary outcome is the comparison between the two study arms with regard to therapy response measured by the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I. The aim of the study is to provide reliable first evidence and effect size measures of rTMS as first-line treatment compared to SSRI treatment. Positive results will help to implement rTMS in early stages of MDD. Trial registration: ClinicalTrials.gov ID: NCT06545474, August 15, 2024. [ABSTRACT FROM AUTHOR]
Copyright of European Archives of Psychiatry & Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Effectiveness of rTMS compared to SSRI as early treatment of depression – study protocol of a randomized controlled trial (Early-TMS).
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  Data: <searchLink fieldCode="JN" term="%22European+Archives+of+Psychiatry+%26+Clinical+Neuroscience%22">European Archives of Psychiatry & Clinical Neuroscience</searchLink>. Sep2025, Vol. 275 Issue 6, p1839-1849. 11p.
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  Data: <searchLink fieldCode="DE" term="%22Mental+depression%22">Mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Transcranial+magnetic+stimulation%22">Transcranial magnetic stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Serotonin+uptake+inhibitors%22">Serotonin uptake inhibitors</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink>
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  Data: Psychotherapy and antidepressant medication are considered first-line treatment options for major depressive disorder (MDD). However, a high proportion of patients do not respond to initial treatment, underlining the need for alternative treatment methods. Repetitive transcranial magnetic stimulation (rTMS) has been established in the treatment of MDD, but the available evidence is limited to forms of MDD with varying degrees of treatment resistance. Randomized-controlled trials (RCT) investigating first-line treatment with rTMS in comparison with first-line antidepressant medication are warranted to further position rTMS within current treatment algorithms for MDD. In this two-stage, therapy response-adapted, randomized multi-center phase 2 rater blinded trial, 106 medication-naïve patients suffering from MDD will be enrolled. In Stage I, participants receive one of the two treatment options for four weeks: either daily bilateral theta burst stimulation (TBS), a patterned and time-saving form of rTMS, or antidepressant medication with selective serotonin reuptake inhibitors (SSRI). The allocation to Stage II occurs therapy response-adapted. Therefore, patients either receive maintenance treatment or will be switched to the respective other treatment arm. Primary outcome is the comparison between the two study arms with regard to therapy response measured by the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I. The aim of the study is to provide reliable first evidence and effect size measures of rTMS as first-line treatment compared to SSRI treatment. Positive results will help to implement rTMS in early stages of MDD. Trial registration: ClinicalTrials.gov ID: NCT06545474, August 15, 2024. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of European Archives of Psychiatry & Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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