Evidence map›Paper›PMID 37817124›Full record

ArticleBMC psychiatry2023

A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression - the U-B-D study protocol.

Molly Watson, Arthur R Chaves, Abir Gebara, Manon Desforges, Antoinette Broomfield, Noémie Landry, Alexandra Lemoyne, Stacey Shim, Jessica Drodge, Jennifer Cuda and 10 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04142996 (A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04142996 narecruitingnot on this map

A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression

TypeinterventionalSponsorThe Royal Ottawa Mental Health CentreRan2019 to 2026Enrolled256ConditionsMajor Depressive EpisodeArmsTheta burst stimulation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Molly Watson *University of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Arthur R Chaves *University of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Abir GebaraSchool of Medicine, Stanford University, 300 Pasteur Drive, Stanford, CA, 94305, USA.
Manon DesforgesUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Antoinette BroomfieldUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Noémie LandryUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Alexandra LemoyneUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Stacey ShimUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Jessica DrodgeUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Jennifer CudaUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Nasim KiaeeUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Youssef NasrUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Christophe CarletonUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Zafiris J DaskalakisDepartment of Psychiatry, University California San Diego, 9500 Gilman Dr, La Jolla, CA, 92093, USA.
Reggie TaylorUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Lauri TuominenUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada.
Ram BrenderDepartment of Psychiatry, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada.
Ruxandra AntochiDepartment of Psychiatry, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada.
Lisa McMurrayDepartment of Psychiatry, University of Ottawa, 451 Smyth Road, Ottawa, ON, K1H 8M5, Canada.
Sara TremblayUniversity of Ottawa Institute of Mental Health Research at The Royal, 1145 Carling Ave, Ottawa, ON, K1Z 7K4, Canada. sara.tremblay@theroyal.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor depressive disorder (MDD) is a prevalent mental health condition affecting millions worldwide, leading to disability and reduced quality of life. MDD poses a global health priority due to its early onset and association with other disabling conditions. Available treatments for MDD exhibit varying effectiveness, and a substantial portion of individuals remain resistant to treatment. Repetitive transcranial magnetic stimulation (rTMS), applied to the left and/or right dorsolateral prefrontal cortex (DLPFC), is an alternative treatment strategy for those experiencing treatment-resistant MDD. The objective of this study is to investigate whether this newer form of rTMS, namely theta burst stimulation (TBS), when performed unilaterally or bilaterally, is efficacious in treatment-resistant MDD.

methodsIn this naturalistic, randomized double-blinded non-inferiority trial, participants with a major depressive episode will be randomized to receive either unilateral (i.e., continuous TBS [cTBS] to the right and sham TBS to the left DLPFC) or bilateral sequential TBS (i.e., cTBS to the right and intermittent TBS [iTBS] to the left DLPFC) delivered 5 days a week for 4-6 weeks. Responders will move onto a 6-month flexible maintenance phase where TBS treatment will be delivered at a decreasing frequency depending on degree of symptom mitigation. Several clinical assessments and neuroimaging and neurophysiological biomarkers will be collected to investigate treatment response and potential associated biomarkers. A non-inferiority analysis will investigate whether bilateral sequential TBS is non-inferior to unilateral TBS and regression analyses will investigate biomarkers of treatment response. We expect to recruit a maximal of 256 participants. This trial is approved by the Research Ethics Board of The Royal's Institute of Mental Health Research (REB# 2,019,071) and will follow the Declaration of Helsinki. Findings will be published in peer-reviewed journals. DISCUSSION: Comprehensive assessment of symptoms and neurophysiological biomarkers will contribute to understanding the differential efficacy of the tested treatment protocols, identifying biomarkers for treatment response, and shedding light into underlying mechanisms of TBS. Our findings will inform future clinical trials and aid in personalizing treatment selection and scheduling for individuals with MDD.

trial registrationThe trial is registered on https://clinicaltrials.gov/ct2/home (#NCT04142996).

Indexed as

Major Depressive DisorderBiomarkersDepressionEquivalence Trials as TopicHumansPrefrontal CortexQuality of LifeRandomized Controlled Trials as TopicTranscranial Magnetic StimulationBiomarkersBiomarkersCorticospinal excitabilityEvoked potentialMagnetic resonance spectroscopyMajor depressive disorderPredictors of responseResting state connectivityTheta burst stimulation (TBS)TMS-EEGTranscranial magnetic stimulation (TMS)

Identifiers

PMID37817124
PMCPMC10566125

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.