Evidence map›Paper›PMID 32499730›Full record

ArticleFrontiers in psychiatry2020

Efficacy, Safety, and Tolerability of Theta-Burst Stimulation in Mixed Depression: Design, Rationale, and Objectives of a Randomized, Double-Blinded, Sham-Controlled Trial.

Diego Freitas Tavares, Carla Garcia Rodrigues Dos Santos, Leandro Da Costa Lane Valiengo, Izio Klein, Lucas Borrione, Pamela Marques Forte, Andre R Brunoni, Ricardo Alberto Moreno

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04123301 (Theta-Burst Stimulation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

NCT04123301 naunknown statusnot on this map

Theta-Burst Stimulation (TBS) in Major Depressive Episodes With Mixed Characteristics in Bipolar and Major Depressive Disorder: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial of Efficacy, Safety, and Tolerability.

TypeinterventionalSponsorUniversity of Sao PauloRan2019 to 2021Enrolled90ConditionsDepressive Episode, Depressive Disorder, Bipolar DisorderArmsActive Theta Burst Stimulation (TBS), Sham Theta Burst Stimulation (TBS)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Treatment of mixed depression with theta-burst stimulation (TBS): results from a double-blind, randomized, sham-controlled clinical trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2021
    Trial
  2. Article
  3. 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

8 authors at 1 institution in 1 country.

Diego Freitas TavaresDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Carla Garcia Rodrigues Dos SantosDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Leandro Da Costa Lane ValiengoDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Izio KleinDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Lucas BorrioneDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Pamela Marques ForteDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Andre R BrunoniDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Ricardo Alberto MorenoDepartment of Psychiatry, University of São Paulo, São Paulo, Brazil.
Universidade de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMixed-specifier mood disorders are probably a different subgroup in terms of response to treatment, socio-demographic parameters, course, and family history. Here we describe the rationale and design of a clinical trial aimed to test the efficacy, safety, and tolerability of a non-pharmacological treatment known as theta-burst stimulation (TBS) for treating the mixed depressive episodes of both bipolar (I or II), and unipolar depression.

methodsThe study is designed as a randomized, sham-controlled, double-blinded clinical trial evaluating TBS for the treatment of moderate or severe major depressive episodes with mixed features of patients receiving at least one first or second-line pharmacological treatment for depressive episodes without adequate response. Ninety adult (18 to 65 years old) patients will be enrolled and submitted to 6-week (comprising 5 consecutive days a week sessions for the first 3 weeks and then 2 days a week for a further 3 week) of inhibitory followed by excitatory TBS in dorsolateral prefrontal cortex. Participants will be assessed using clinical and neuropsychological tests before and after the intervention. The primary outcome is change in Montgomery-Åsberg Depression Scale (MADRS) score over time and across groups. Cognitive parameters will also be assessed with neuropsychological tests.

resultsThe clinical results will provide evidence about TBS as an adjunctive treatment for mixed depression treatment and neuropsychological parameters will contribute toward an improved understanding the effects of TBS in cognition.

conclusionOur results could introduce a novel therapeutic technique for mixed depressive episodes of both bipolar and unipolar disorders. CLINICAL

trial registrationwww.ClinicalTrials.gov, identifier NCT04123301; date of registration: 10/10/2019; URL: https://clinicaltrials.gov/ct2/show/NCT04123301?term=NCT04123301&rank=1.

Indexed as

bipolar disorderdepressionmixed states/episodesrandomized controlled (clinical) trialtranscranial stimulation

Identifiers

PMID32499730
PMCPMC7242745
OpenAlexW3025344375

What OpenQuestion holds

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LicenceCC BY
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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.