Evidence map›Paper›PMID 38425284›Full record

Trial reportCanadian journal of psychiatry. Revue canadienne de psychiatrie2024

Adjunctive Brexpiprazole for Patient Life Engagement in Major Depressive Disorder: A Canadian, Phase 4, Open-Label, Interventional Study: Brexpiprazole d'appoint pour l'engagement dans la vie des patients souffrant de trouble dépressif majeur: une étude interventionnelle canadienne ouverte de phase 4.

François Therrien, Caroline Ward, Pratap Chokka, Jeffrey Habert, Zahinoor Ismail, Roger S McIntyre, Erin M MacKenzie

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVMulticenter Study
In one paragraph

Trial report in Canadian journal of psychiatry. Revue canadienne de psychiatrie, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04830215 (A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole), 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
2.2field-weighted citation impact, top 14% 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.

NCT04830215 phase4completednot on this map

A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2021 to 2022Enrolled122ConditionsMajor Depressive DisorderArmsBrexpiprazole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Evaluation of brexpiprazole as adjunctive therapy in treatment-resistant depression: Real-world data.Dusunen adam : Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi yayin organi · 2026
    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

7 authors at 4 institutions in 3 countries.

François TherrienOtsuka Canada Pharmaceutical Inc., Saint-Laurent, Quebec, Canada.
Caroline WardOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey, USA.
Pratap ChokkaChokka Center for Integrative Health, Edmonton, Alberta, Canada.
Jeffrey HabertDepartment of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0003-0009-3182
Zahinoor IsmailDepartments of Psychiatry, Clinical Neurosciences, and Community Health Sciences; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.ORCID 0000-0002-5529-3731
Roger S McIntyreDepartment of Psychiatry and Department of Pharmacology & Toxicology, University of Toronto, Toronto, Ontario, Canada.
Erin M MacKenzieLundbeck Canada Inc., Saint-Laurent, Quebec, Canada.
University of Toronto · CAOtsuka (United States) · USUniversity of Alberta · CAUniversity of Calgary · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo characterize the effects of adjunctive brexpiprazole on patient life engagement and depressive symptoms in patients with major depressive disorder (MDD) using patient-reported outcomes.

methodsAn 8-week, Phase 4, open-label, interventional study was conducted at 15 Canadian trial sites between April 2021 and May 2022. Adult outpatients with MDD (at least moderately severe) and inadequate response to 1-2 antidepressants continued their current antidepressant and received oral adjunctive brexpiprazole 0.5-2 mg/day. Co-primary endpoints were change from baseline to Week 8 in Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-item Life Engagement subscale score, and IDS-SR 30-item total score. Safety was assessed by standard variables.

resultsOf 122 enrolled patients, 120 (98.4%) were treated (mean [

conclusionsUsing an exploratory patient-reported outcome measure, patients with MDD and inadequate response to antidepressants who received open-label adjunctive brexpiprazole showed early and clinically meaningful improvement in patient life engagement, which should be further assessed in a prospective randomized controlled trial. Patient-rated depressive symptoms (on the validated 30-item IDS-SR) also improved. Adjunctive brexpiprazole was well tolerated, and no new safety signals were observed. CLINICAL

trial registrationClinicalTrials.gov identifier: NCT04830215.

Indexed as

Antidepressive AgentsMajor Depressive DisorderPatient Reported Outcome MeasuresQuinolonesThiophenesAdultCanadaDrug Therapy, CombinationFemaleHumansMaleMiddle AgedAntidepressive AgentsbrexpiprazoleQuinolonesThiophenesactivités de la vie quotidienneactivities of daily livingantidepressantantidépresseuranxiétéanxietybien-être psychologiquebrexpiprazoledepressiondépressionfonctionnement psychosocialmajor depressive disordermesures des résultats évaluées par le patientpatient-reported outcome measurespsychological well-beingpsychosocial functioningqualité de viequality of lifetrouble dépressif majeur

Identifiers

PMID38425284
PMCPMC11168343
OpenAlexW4392366224

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.