Evidence map›Paper›PMID 36581972›Full record

ArticleBMJ open2022

Association of intranasal esketamine, a novel 'standard of care' treatment and outcomes in the management of patients with treatment-resistant depression: protocol of a prospective cohort observational study of naturalistic clinical practice.

Gustavo Vazquez, Gilmar Gutierrez, Joshua Rosenblat, Ayal Schaffer, Jennifer Swainson, Ganapathy Karthikeyan, Nisha Ravindran, Raymond W Lam, André Do, Peter Giacobbe and 2 more

Abstract read
In one paragraph

Article in BMJ open, 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
–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.

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.

  1. Article
  2. Article
  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

12 authors.

Gustavo VazquezPsychiatry, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada g.vazquez@queensu.ca.
Gilmar GutierrezSchool of Medicine, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.ORCID 0000-0003-0337-3737
Joshua RosenblatPsychiatry, University of Toronto, Toronto, Ontario, Canada.
Ayal SchafferPsychiatry, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Jennifer SwainsonDepartment of Psychiatry, University of Alberta, Edmonton, Alberta, Canada.
Ganapathy KarthikeyanPsychiatry, Alberta Hospital Edmonton, Edmonton, Alberta, Canada.
Nisha RavindranPsychiatry, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-0468-1099
Raymond W LamPsychiatry, The University of British Columbia, Vancouver, British Columbia, Canada.
André DoDepartment of Psychiatry, The University of British Columbia, Vancouver, British Columbia, Canada.
Peter GiacobbePsychiatry, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Emily HawkenPsychiatry, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.
Roumen MilevPsychiatry, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEsketamine is the S-enantiomer of racemic ketamine and has been approved by the Food and Drug Administration for the management of treatment resistant depression, demonstrating effective and long-lasting benefits. The objective of this observational study is to elucidate the association of intranasal (IN) esketamine with beneficial and negative outcomes in the management of treatment resistant major depressive disorder. METHODS AND ANALYSIS: This is a multicentre prospective cohort observational study of naturalistic clinical practice. We expect to recruit 10 patients per research centre (6 centres, total 60 subjects). After approval to receive IN esketamine as part of their standard of care management of moderate to severe treatment resistant depression, patients will be invited to participate in this study. Association of esketamine treatment with outcomes in the management of depression will be assessed by measuring the severity of depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS), and tolerability by systematically tracking common side effects of ketamine treatment, dissociation using the simplified 6-Item Clinician Administered Dissociative Symptom Scale and potential for abuse using the Likeability and Craving Questionnaire (LCQ). Change in depressive symptoms (MADRS total scores) over time will be evaluated by within-subject repeated measures analysis of variance. We will calculate the relative risk associated with the beneficial (reduction in total scores for depression) outcomes, and the side effect and dropout rates (tolerability) of adding IN esketamine to patients' current pharmacological treatments. Covariate analysis will assess the impact of site and demographic variables on treatment outcomes. ETHICS AND DISSEMINATION: Approval to perform this study was obtained through the Health Sciences Research Ethics Board at Queen's University. Findings will be shared among collaborators, through departmental meetings, presented on different academic venues and publishing our manuscript.

Indexed as

Depressive Disorder, Treatment-ResistantDrug-Related Side Effects and Adverse ReactionsKetamineMajor Depressive DisorderAntidepressive AgentsDepressionHumansMulticenter Studies as TopicObservational Studies as TopicProspective StudiesTreatment OutcomeAntidepressive AgentsEsketamineKetamineAdult psychiatryDepression & mood disordersMENTAL HEALTH

Identifiers

PMID36581972
PMCPMC9438206

What OpenQuestion holds

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LicenceCC BY-NC
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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.