Treatment of major depressive disorder with bilateral theta burst stimulation (TBS-D)

ID

56

DZPG Site

Tübingen
General Information
Status

Ongoing (II): Recruitment and data collection ongoing

Description

To test the superiority of augmentative bilateral theta burst stimulation compared to placebo on MDD treatment response rates.

Paper

Plewnia et al. (2021). Treatment of major depressive disorder with bilateral theta burst stimulation: study protocol for a randomized, double‑blind, placebo‑controlled multicenter trial (TBS‑D). European Archives of Psychiatry and Clinical Neuroscience 271:1231-1243 https://link.springer.com/article/10.1007/s00406-021-01280-w

Trial Number

NCT04392947

Contact
PI

Prof. Dr. Christian Plewnia

Further PIs

Prof. Dr. med. Andreas J. Fallgatter

Survey Results
Is it an interventional or non-interventional study?
  • Interventional
Specification of study type
  • Parallel
Is it a mono- or multicentric study?

Multicentric

Number of sites

7

Is it a single or multi country study?

Single

Which country?

Germany

Who are participants?
  • Patients with specific diseases
Which diseases? (ICD-11 classification)
  • Mental, behavioural or neurodevelopmental disorders (06)
Mental, behavioural or neurodevelopmental disorders (ICD-11 classification)
  • Mood disorders
Recruitment setting
  • Outpatient
Target sample size

236

Obtained sample size

155

Start of recruitment

2021

Minimum age of participants

18

Maximum age of participants

70

Data sources for the study
  • Biological samples
  • Cognitive measurements
  • Imaging data
  • Medical records
  • Interview
  • Questionnaire
  • Omics technology
Is it planned to share the data?

Undecided, it is not yet known if data will be made available

Are further follow-ups planned?

Not planned, but possible

Is there consent to re-contact participants?

Yes

Is the implementation of further study components possible?

No

Biobank Module
Which material did you collect?
  • Blood
What type of blood collection tubes did you use?
  • EDTA
  • PAXgene/Tempus
Which type of data did you collect from EDTA?
  • Genetic
  • Epigenetic
Which data did you collect from PAXgene/Tempus?
  • Gene expression
View raw data