Evidence map›Paper›PMID 30508090›Full record

ArticleThe international journal of neuropsychopharmacology2019

Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale.

Mary Hobart, Peter Zhang, Catherine Weiss, Stine Rasmussen Meehan, Hans Eriksson

6 registry-linked trialsAbstract read
In one paragraph

Article in The international journal of neuropsychopharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–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.

NCT00797966 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2009 to 2010Enrolled850ConditionsMajor Depressive DisorderArmsOPC-34712, Placebo, ADT
NCT01052077 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2010 to 2011Enrolled773ConditionsMajor Depressive DisorderArmsOPC-34712, Placebo, ADT
NCT01360632 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2011 to 2013Enrolled1,539ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood DisordersArmsOPC-34712 + ADT, Placebo + ADT
NCT01360645 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2011 to 2013Enrolled826ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood DisordersArmsOPC-34712 + ADT, Placebo + ADT
NCT01727726 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2012 to 2016Enrolled2,182ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood DisordersArmsBrexpiprazole, Seroquel XR, Placebo
NCT02196506 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2014 to 2016Enrolled837ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood DisordersArmsPlacebo + ADT, Brexpiprazole +ADT
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Interventions to improve return to work in depressed people.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Psychophysical and Social Functioning of Patients with Chronic Obstructive Lung Disease and Depression.European journal of investigation in health, psychology and education · 2023
    Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. 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

5 authors.

Mary HobartOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson).
Peter ZhangOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson).
Catherine WeissOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson).
Stine Rasmussen MeehanOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson).
Hans ErikssonOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey (Drs Hobart, Zhang, and Weiss); H. Lundbeck A/S, Valby, Denmark (Drs Meehan and Eriksson).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with major depressive disorder and inadequate response to antidepressant treatments may experience a prolonged loss of functioning. This post hoc analysis aimed to determine the effect of adjunctive brexpiprazole on functioning in such patients.

methodsA pooled analysis of data from the 6-week, randomized, double-blind treatment phases of 6 studies of adjunctive brexpiprazole (2 and 3 mg/d in fixed-dose studies; 1-3 mg/d in flexible-dose studies) vs placebo in patients with major depressive disorder and inadequate response to antidepressant treatments (NCT01360645, NCT01360632, NCT02196506, NCT01727726, NCT00797966, NCT01052077). Functioning was measured by change in Sheehan Disability Scale score from baseline to week 6.

resultsConsidering Sheehan Disability Scale mean score across all 6 studies (n = 2066 randomized), the least squares mean difference between antidepressant treatments + brexpiprazole and antidepressant treatments + placebo at week 6 was -0.40 (95% CI: -0.56, -0.23; P < .0001). Antidepressant treatments + brexpiprazole showed a greater benefit than antidepressant treatments + placebo on the social life (-0.45; -0.63, -0.27; P < .001) and family life (-0.50; -0.70, -0.31; P < .001) items but not on the work/studies item (-0.16; -0.38, 0.06; P = .16). Pooled analyses of just the (1) fixed-dose, (2) flexible-dose, and (3) Phase 3 studies showed the same pattern of benefits for antidepressant treatments + brexpiprazole.

conclusionsBrexpiprazole, as adjunct to antidepressant treatments, improved functioning in patients with major depressive disorder and inadequate response to antidepressant treatments.

Indexed as

Disability EvaluationAntidepressive AgentsDouble-Blind MethodDrug Therapy, CombinationHumansMajor Depressive DisorderProspective StudiesQuinolonesRandomized Controlled Trials as TopicSerotonin AgentsSingle-Blind MethodThiophenesAntidepressive AgentsbrexpiprazoleQuinolonesSerotonin AgentsThiophenesadjunctivebrexpiprazoledepressionfunctioningSheehan Disability Scale

Identifiers

PMID30508090
PMCPMC6403084

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.