Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D).
Saved in:
| Title: | Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D). |
|---|---|
| Authors: | Plewnia, Christian (AUTHOR), Brendel, Bettina (AUTHOR), Schwippel, Tobias (AUTHOR), Nieratschker, Vanessa (AUTHOR), Ethofer, Thomas (AUTHOR), Kammer, Thomas (AUTHOR), Padberg, Frank (AUTHOR), Martus, Peter (AUTHOR), Fallgatter, Andreas J. (AUTHOR) |
| Source: | European Archives of Psychiatry & Clinical Neuroscience. Oct2021, Vol. 271 Issue 7, p1231-1243. 13p. 2 Diagrams, 2 Charts. |
| Subjects: | Mental depression, Research protocols, Transcranial magnetic stimulation, Transcranial direct current stimulation, Brain stimulation, Prefrontal cortex, Randomized controlled trials |
| Abstract: | Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (dlPFC) is currently evolving as an effective and safe therapeutic tool in the treatment of major depressive disorder (MDD). However, already established rTMS treatment paradigms are rather time-consuming. With theta burst stimulation (TBS), a patterned form of rTMS, treatment time can be substantially reduced. Pilot studies and a randomized controlled trial (RCT) demonstrate non-inferiority of TBS to 10 Hz rTMS and support a wider use in MDD. Still, data from placebo-controlled multicenter RCTs are lacking. In this placebo-controlled multicenter study, 236 patients with MDD will be randomized to either intermittent TBS (iTBS) to the left and continuous TBS (cTBS) to the right dlPFC or bilateral sham stimulation (1:1 ratio). The treatment will be performed with 80% resting motor threshold intensity over six consecutive weeks (30 sessions). The primary outcome is the treatment response rate (Montgomery-Asberg Depression Rating Scale reduction ≥ 50%). The aim of the study is to confirm the superiority of active bilateral TBS compared to placebo treatment. In two satellite studies, we intend to identify possible MRI-based and (epi-)genetic predictors of responsiveness to TBS therapy. Positive results will support the clinical use of bilateral TBS as an advantageous, efficient, and well-tolerated treatment and pave the way for further individualization of MDD therapy. Trial registration: ClinicalTrials.gov (NCT04392947). [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.) | |
| Database: | Psychology and Behavioral Sciences Collection |
|
Full text is not displayed to guests.
Login for full access.
|
|
| FullText | Links: – Type: pdflink Text: Availability: 1 |
|---|---|
| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 152371942 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
| IllustrationInfo | |
| Items | – Name: Title Label: Title Group: Ti Data: Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D). – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Plewnia%2C+Christian%22">Plewnia, Christian</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Brendel%2C+Bettina%22">Brendel, Bettina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Schwippel%2C+Tobias%22">Schwippel, Tobias</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Nieratschker%2C+Vanessa%22">Nieratschker, Vanessa</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ethofer%2C+Thomas%22">Ethofer, Thomas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Kammer%2C+Thomas%22">Kammer, Thomas</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Padberg%2C+Frank%22">Padberg, Frank</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Martus%2C+Peter%22">Martus, Peter</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fallgatter%2C+Andreas+J%2E%22">Fallgatter, Andreas J.</searchLink> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22European+Archives+of+Psychiatry+%26+Clinical+Neuroscience%22">European Archives of Psychiatry & Clinical Neuroscience</searchLink>. Oct2021, Vol. 271 Issue 7, p1231-1243. 13p. 2 Diagrams, 2 Charts. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Mental+depression%22">Mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Research+protocols%22">Research protocols</searchLink><br /><searchLink fieldCode="DE" term="%22Transcranial+magnetic+stimulation%22">Transcranial magnetic stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Transcranial+direct+current+stimulation%22">Transcranial direct current stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Brain+stimulation%22">Brain stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Prefrontal+cortex%22">Prefrontal cortex</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (dlPFC) is currently evolving as an effective and safe therapeutic tool in the treatment of major depressive disorder (MDD). However, already established rTMS treatment paradigms are rather time-consuming. With theta burst stimulation (TBS), a patterned form of rTMS, treatment time can be substantially reduced. Pilot studies and a randomized controlled trial (RCT) demonstrate non-inferiority of TBS to 10 Hz rTMS and support a wider use in MDD. Still, data from placebo-controlled multicenter RCTs are lacking. In this placebo-controlled multicenter study, 236 patients with MDD will be randomized to either intermittent TBS (iTBS) to the left and continuous TBS (cTBS) to the right dlPFC or bilateral sham stimulation (1:1 ratio). The treatment will be performed with 80% resting motor threshold intensity over six consecutive weeks (30 sessions). The primary outcome is the treatment response rate (Montgomery-Asberg Depression Rating Scale reduction ≥ 50%). The aim of the study is to confirm the superiority of active bilateral TBS compared to placebo treatment. In two satellite studies, we intend to identify possible MRI-based and (epi-)genetic predictors of responsiveness to TBS therapy. Positive results will support the clinical use of bilateral TBS as an advantageous, efficient, and well-tolerated treatment and pave the way for further individualization of MDD therapy. Trial registration: ClinicalTrials.gov (NCT04392947). [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab 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.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=152371942 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s00406-021-01280-w Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 13 StartPage: 1231 Subjects: – SubjectFull: Mental depression Type: general – SubjectFull: Research protocols Type: general – SubjectFull: Transcranial magnetic stimulation Type: general – SubjectFull: Transcranial direct current stimulation Type: general – SubjectFull: Brain stimulation Type: general – SubjectFull: Prefrontal cortex Type: general – SubjectFull: Randomized controlled trials Type: general Titles: – TitleFull: Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double-blind, placebo-controlled multicenter trial (TBS-D). Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Plewnia, Christian – PersonEntity: Name: NameFull: Brendel, Bettina – PersonEntity: Name: NameFull: Schwippel, Tobias – PersonEntity: Name: NameFull: Nieratschker, Vanessa – PersonEntity: Name: NameFull: Ethofer, Thomas – PersonEntity: Name: NameFull: Kammer, Thomas – PersonEntity: Name: NameFull: Padberg, Frank – PersonEntity: Name: NameFull: Martus, Peter – PersonEntity: Name: NameFull: Fallgatter, Andreas J. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 10 Text: Oct2021 Type: published Y: 2021 Identifiers: – Type: issn-print Value: 09401334 Numbering: – Type: volume Value: 271 – Type: issue Value: 7 Titles: – TitleFull: European Archives of Psychiatry & Clinical Neuroscience Type: main |
| ResultId | 1 |
