## Early intervention with repetitive theta burst stimulation in adolescents and young adults with depressive disorders: a sequential Bayesian, randomized controlled pilot trial (EARLY-BURST)
### Description
The development of early interventions for young patients with depressive disorders is a top research priority for patients and care providers. Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (lDLPFC) is a safe neuromodulatory intervention that reduces depressive symptoms across diagnostic categories in adults. However, it has not been investigated as an early intervention in young patients. In the EARLY-BURST pilot trial, we will investigate the antidepressant efficacy of 6 weeks’ lDLPFC intermittent theta burst stimulation (iTBS) versus sham iTBS in adolescents and young adults with depressive disorders and no antidepressant or antipsychotic medication during the last 12 months (except for short-term on-demand medication), allowing for relevant comorbidities. We will apply a sequential Bayesian, triple-blind, randomized, controlled design that allows early stopping in case of clearly superior or absent between-group effects. Participants will be invited to follow-up visits at 3 and 6 months after randomization to explore the potential long-term effects of the treatment.
### Pre-registration
DRKS: [DRKS00033313][1]
### Study team
**Department of Psychiatry and Psychotherapy, LMU University Hospital, Munich, Germany**
- Dr. Gerrit Burkhardt
- Prof. Dr. Frank Padberg
- Dr. Jonas Björklund
- Miaoxi Chen, M.Sc.
- Dr. Lucia Bulubas, Ph.D.
- Esther Dechantsreiter, M.Sc.
**Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, LMU University Hospital, Munich, Germany**
- Prof. Dr. Gerd Schulte-Körne
- Prof. Ellen Greimel, Ph.D.
- Lisa Feldmann, Ph.D.
- Dr. Alina Schaeffler
- Dr. Aline Scherff
**Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, University of
Augsburg, Augsburg, Germany**
- Prof. Dr. Alkomiet Hasan
- Dr. Wolfgang Strube
- Thomas Görlitz
- Anja Baumgartner
- Marco Poli
**Department of Clinical Psychology and Experimental Psychopathology, Institute of Psychology, Georg-August-University of Göttingen, Göttingen, Germany**
- Simon Blackwell, Ph.D.
**Patient and Public Involvement**
- Peter Bechmann
- Armin Kauf
#### Contact
Dr. Gerrit Burkhardt\
ORCID: https://orcid.org/0000-0003-3965-5664\
Institution: Department of Psychiatry and Psychotherapy, [LMU University Hospital, Munich, Germany][2]\
Email: gerrit.burkhardt@med.uni-muenchen.de
### Date of data collection:
* Start of recruitment: 20240401
### Geographic location of data collection
- Munich, Germany
- Augsburg, Germany
### Funding sources
Funder: Bundesministerium für Bildung und Forschung\
Award title: DZPG Aufbauförderung - "Standort München"\
Award info URI: https://www.gesundheitsforschung-bmbf.de/de/dzpg-aufbauforderung-standort-munchen-16573.php\
Award number: 01EE2303A
### Data & File overview
**Code**
* *RetrieveSims.13.09.24.r2024*: Script for updated sample size calculations based on an effect size of d=0.6 (study protocol version 1.3)
* *RetrieveSims.28.03.23.r2024*: Script for the initial sample size calculations based on an effect size of d=0.8
**Data**
**Documents**
* *EARLYBURST_ClinicalProtocol.pdf2024*: study protocol
* *EARLYBURST_Patinfo_Erwachsene.pdf2024*: Informed consent and information form for adult participants
* *EARLYBURST_Patinfo_JugendlicheUndEltern.pdf2024*: Informed consent and information form for adolescent participants
* *Simulations_ef0.6_13.09.24.docx2024*: results of the updated sample size calculations based on an effect size of d=0.6 (study protocol version 1.3)
**Manuscript files**
### Sharing/Access Data
Licenses/restrictions placed on the data: CC-By Attribution 4.0 International
[1]: https://drks.de/search/de/trial/DRKS00033313
