View in EDS HTML Full Text PDF Full Text

Intermittent theta burst stimulation in adolescents and young adults with depressive disorders: protocol of a randomized, sham-controlled study with a sequential Bayesian design for adaptive trials.

Saved in:
Bibliographic Details
Title: Intermittent theta burst stimulation in adolescents and young adults with depressive disorders: protocol of a randomized, sham-controlled study with a sequential Bayesian design for adaptive trials.
Authors: Burkhardt, Gerrit (AUTHOR), Blackwell, Simon E. (AUTHOR), Chen, Miaoxi (AUTHOR), Feldmann, Lisa (AUTHOR), Björklund, Jonas (AUTHOR), Dechantsreiter, Esther (AUTHOR), Bulubas, Lucia (AUTHOR), Goerigk, Stephan (AUTHOR), Keeser, Daniel (AUTHOR), Falkai, Peter (AUTHOR), Greimel, Ellen (AUTHOR), Bechmann, Peter (AUTHOR), Schulte-Körne, Gerd (AUTHOR), Hasan, Alkomiet (AUTHOR), Strube, Wolfgang (AUTHOR), Padberg, Frank (AUTHOR)
Source: European Archives of Psychiatry & Clinical Neuroscience. Sep2025, Vol. 275 Issue 6, p1827-1838. 12p.
Subjects: Mental depression, Young adults, Teenagers, Transcranial magnetic stimulation, Randomized controlled trials, Treatment effectiveness, Safety
Abstract: Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is an established treatment for adults with major depressive disorder (MDD). Due to its favorable safety profile, iTBS is also a promising early intervention in the transition phase from adolescence to early adulthood, but this has not been systematically investigated to date. Thus, the EARLY-BURST trial investigates the efficacy and safety of iTBS over the left dorsolateral prefrontal cortex (lDLPFC) in treatment-seeking young patients (age 16–26 years) with depressive disorders (i.e. major depressive disorder, persistent depressive disorder, bipolar depression), allowing for relevant co-morbidities. Participants have not received antidepressant or antipsychotic medication during the last 12 months except for short-term (< 2 weeks) on-demand medication. The trial will employ a novel sequential Bayesian, randomized, double-blind, parallel-group, sham-controlled design. Up to 90 patients at two clinical sites (Munich, Augsburg) will be randomized 1:1 to the treatment groups, with sequential analyses starting after 26 patients in each group completed the treatment. The primary outcome will be the difference in depression severity at week 6 (post-treatment visit) between active iTBS and sham iTBS, assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS). The trial is planned to be expanded towards a three-arm leapfrog design, contingent on securing additional funding. Thus, in addition to potentially providing evidence of iTBS's efficacy in adolescents and young adults with depressive disorders, the EARLY-BURST trial aims at setting the stage for subsequent platform trials in this dynamic research field, where novel adaptive study designs are required to meet the need for rapidly testing promising new vs established rTMS protocols. Trial registration: DRKS00033313. [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.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 188476043
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Intermittent theta burst stimulation in adolescents and young adults with depressive disorders: protocol of a randomized, sham-controlled study with a sequential Bayesian design for adaptive trials.
– Name: Author
  Label: Authors
  Group: Au
  Data: &lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Burkhardt%2C+Gerrit%22&quot;&gt;Burkhardt, Gerrit&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Blackwell%2C+Simon+E%2E%22&quot;&gt;Blackwell, Simon E.&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Chen%2C+Miaoxi%22&quot;&gt;Chen, Miaoxi&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Feldmann%2C+Lisa%22&quot;&gt;Feldmann, Lisa&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Bj&#246;rklund%2C+Jonas%22&quot;&gt;Bj&#246;rklund, Jonas&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Dechantsreiter%2C+Esther%22&quot;&gt;Dechantsreiter, Esther&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Bulubas%2C+Lucia%22&quot;&gt;Bulubas, Lucia&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Goerigk%2C+Stephan%22&quot;&gt;Goerigk, Stephan&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Keeser%2C+Daniel%22&quot;&gt;Keeser, Daniel&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Falkai%2C+Peter%22&quot;&gt;Falkai, Peter&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Greimel%2C+Ellen%22&quot;&gt;Greimel, Ellen&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Bechmann%2C+Peter%22&quot;&gt;Bechmann, Peter&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Schulte-K&#246;rne%2C+Gerd%22&quot;&gt;Schulte-K&#246;rne, Gerd&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Hasan%2C+Alkomiet%22&quot;&gt;Hasan, Alkomiet&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Strube%2C+Wolfgang%22&quot;&gt;Strube, Wolfgang&lt;/searchLink&gt; (AUTHOR)&lt;br /&gt;&lt;searchLink fieldCode=&quot;AR&quot; term=&quot;%22Padberg%2C+Frank%22&quot;&gt;Padberg, Frank&lt;/searchLink&gt; (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: &lt;searchLink fieldCode=&quot;JN&quot; term=&quot;%22European+Archives+of+Psychiatry+%26+Clinical+Neuroscience%22&quot;&gt;European Archives of Psychiatry &amp; Clinical Neuroscience&lt;/searchLink&gt;. Sep2025, Vol. 275 Issue 6, p1827-1838. 12p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: &lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Mental+depression%22&quot;&gt;Mental depression&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Young+adults%22&quot;&gt;Young adults&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Teenagers%22&quot;&gt;Teenagers&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Transcranial+magnetic+stimulation%22&quot;&gt;Transcranial magnetic stimulation&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Randomized+controlled+trials%22&quot;&gt;Randomized controlled trials&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Treatment+effectiveness%22&quot;&gt;Treatment effectiveness&lt;/searchLink&gt;&lt;br /&gt;&lt;searchLink fieldCode=&quot;DE&quot; term=&quot;%22Safety%22&quot;&gt;Safety&lt;/searchLink&gt;
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Intermittent theta burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is an established treatment for adults with major depressive disorder (MDD). Due to its favorable safety profile, iTBS is also a promising early intervention in the transition phase from adolescence to early adulthood, but this has not been systematically investigated to date. Thus, the EARLY-BURST trial investigates the efficacy and safety of iTBS over the left dorsolateral prefrontal cortex (lDLPFC) in treatment-seeking young patients (age 16–26 years) with depressive disorders (i.e. major depressive disorder, persistent depressive disorder, bipolar depression), allowing for relevant co-morbidities. Participants have not received antidepressant or antipsychotic medication during the last 12 months except for short-term (&lt; 2 weeks) on-demand medication. The trial will employ a novel sequential Bayesian, randomized, double-blind, parallel-group, sham-controlled design. Up to 90 patients at two clinical sites (Munich, Augsburg) will be randomized 1:1 to the treatment groups, with sequential analyses starting after 26 patients in each group completed the treatment. The primary outcome will be the difference in depression severity at week 6 (post-treatment visit) between active iTBS and sham iTBS, assessed with the Montgomery-&#197;sberg Depression Rating Scale (MADRS). The trial is planned to be expanded towards a three-arm leapfrog design, contingent on securing additional funding. Thus, in addition to potentially providing evidence of iTBS&#39;s efficacy in adolescents and young adults with depressive disorders, the EARLY-BURST trial aims at setting the stage for subsequent platform trials in this dynamic research field, where novel adaptive study designs are required to meet the need for rapidly testing promising new vs established rTMS protocols. Trial registration: DRKS00033313. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: &lt;i&gt;Copyright of European Archives of Psychiatry &amp; Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder&#39;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.&lt;/i&gt; (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=188476043
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1007/s00406-024-01926-5
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 12
        StartPage: 1827
    Subjects:
      – SubjectFull: Mental depression
        Type: general
      – SubjectFull: Young adults
        Type: general
      – SubjectFull: Teenagers
        Type: general
      – SubjectFull: Transcranial magnetic stimulation
        Type: general
      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Treatment effectiveness
        Type: general
      – SubjectFull: Safety
        Type: general
    Titles:
      – TitleFull: Intermittent theta burst stimulation in adolescents and young adults with depressive disorders: protocol of a randomized, sham-controlled study with a sequential Bayesian design for adaptive trials.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Burkhardt, Gerrit
      – PersonEntity:
          Name:
            NameFull: Blackwell, Simon E.
      – PersonEntity:
          Name:
            NameFull: Chen, Miaoxi
      – PersonEntity:
          Name:
            NameFull: Feldmann, Lisa
      – PersonEntity:
          Name:
            NameFull: Björklund, Jonas
      – PersonEntity:
          Name:
            NameFull: Dechantsreiter, Esther
      – PersonEntity:
          Name:
            NameFull: Bulubas, Lucia
      – PersonEntity:
          Name:
            NameFull: Goerigk, Stephan
      – PersonEntity:
          Name:
            NameFull: Keeser, Daniel
      – PersonEntity:
          Name:
            NameFull: Falkai, Peter
      – PersonEntity:
          Name:
            NameFull: Greimel, Ellen
      – PersonEntity:
          Name:
            NameFull: Bechmann, Peter
      – PersonEntity:
          Name:
            NameFull: Schulte-Körne, Gerd
      – PersonEntity:
          Name:
            NameFull: Hasan, Alkomiet
      – PersonEntity:
          Name:
            NameFull: Strube, Wolfgang
      – PersonEntity:
          Name:
            NameFull: Padberg, Frank
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 09
              Text: Sep2025
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-print
              Value: 09401334
          Numbering:
            – Type: volume
              Value: 275
            – Type: issue
              Value: 6
          Titles:
            – TitleFull: European Archives of Psychiatry & Clinical Neuroscience
              Type: main
ResultId 1