Evidence map›Paper›PMID 35123427›Full record

ArticleBMC psychiatry2022

rTMS combined with CBT as a next step in antidepressant non-responders: a study protocol for a randomized comparison with current antidepressant treatment approaches.

Iris Dalhuisen, Filip Smit, Jan Spijker, Iris van Oostrom, Eric van Exel, Hans van Mierlo, Dieuwertje de Waardt, Martijn Arns, Indira Tendolkar, Philip van Eijndhoven

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 38% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
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

10 authors at 7 institutions in 1 country.

Iris DalhuisenDepartment of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands. iris.dalhuisen@radboudumc.nl.ORCID 0000-0002-7539-6498
Filip SmitDepartment of Clinical Psychology and Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.
Jan SpijkerDepression Expertise Centre, Pro Persona Mental Health Care, Nijmegen, The Netherlands.
Iris van OostromNeurocare, Nijmegen, The Netherlands.
Eric van ExelDepartment of Psychiatry, GGZ inGeest Specialized Mental Health Care, Amsterdam, Netherlands.
Hans van MierloDepartment of Psychiatry & Psychology, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands.
Dieuwertje de WaardtDepartment of Psychiatry, ETZ Hospital (Elisabeth-TweeSteden Ziekenhuis), Tilburg, The Netherlands.
Martijn ArnsResearch Institute Brainclinics, Nijmegen, The Netherlands.
Indira TendolkarDepartment of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.
Philip van EijndhovenDepartment of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands.
Radboud University Nijmegen · NLElisabeth-TweeSteden Ziekenhuis · NLGGZ inGeest · NLMaastricht University · NLNetherlands Institute for Neuroscience · NLSt. Antonius Ziekenhuis · NLTrimbos Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMajor depressive disorder (MDD) is one of the most common psychiatric disorders, however, current treatment options are insufficiently effective for about 35% of patients, resulting in treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is a form of non-invasive neuromodulation that is effective in treating TRD. Not much is known about the comparative efficacy of rTMS and other treatments and their timing within the treatment algorithm, making it difficult for the treating physician to establish when rTMS is best offered as a treatment option. This study aims to investigate the (cost-)effectiveness of rTMS (in combination with cognitive behavioral therapy (CBT) and continued antidepressant medication), compared to the next step in the treatment algorithm. This will be done in a sample of patients with treatment resistant non-psychotic unipolar depression.

methodsIn this pragmatic multicenter randomized controlled trial 132 patients with MDD are randomized to either rTMS or the next pharmacological step within the current treatment protocol (a switch to a tricyclic antidepressant or augmentation with lithium or a second-generation antipsychotic). Both groups also receive CBT. The trial consists of 8 weeks of unblinded treatment followed by follow-up of the cohort at four and 6 months. A subgroup of patients (n = 92) will have an extended follow-up at nine and 12 months to assess effect decay or retention. We expect that rTMS is more (cost-)effective than medication in reducing depressive symptoms in patients with TRD. We will also explore the effects of both treatments on symptoms associated with depression, e.g. anhedonia and rumination, as well as the effect of expectations regarding the treatments on its effectiveness. DISCUSSION: The present trial aims to inform clinical decision making about whether rTMS should be considered as a treatment option in patients with TRD. The results may improve treatment outcomes in patients with TRD and may facilitate adoption of rTMS in the treatment algorithm for depression and its implementation in clinical practice.

trial registrationThis trial is registered within the Netherlands Trial Register (code: NL7628 , date: March 29th 2019).

Indexed as

Cognitive Behavioral TherapyDepressive Disorder, Treatment-ResistantMajor Depressive DisorderAntidepressive AgentsHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTranscranial Magnetic StimulationAntidepressive Agents(cost)-effectivenessDepressionRCTrTMS

Identifiers

PMID35123427
PMCPMC8818163
OpenAlexW4210482068

What OpenQuestion holds

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Registered trials

None linked

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.