Evidence map›Paper›PMID 27784751›Full record

Trial reportThe international journal of neuropsychopharmacology2017

Switching from Inadequate Adjunctive or Combination Treatment Options to Brexpiprazole Adjunctive to Antidepressant: An Open-Label Study on the Effects on Depressive Symptoms and Cognitive and Physical Functioning.

Maurizio Fava, Takao Okame, Yuki Matsushima, Pamela Perry, Emmanuelle Weiller, Ross A Baker

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The international journal of neuropsychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02012218 (A Phase 3b, Multicenter, Open-label Exploratory Trial to Evaluate the Efficacy, Safety, and Subject Satisfaction With Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT02012218 phase3completednot on this map

A Phase 3b, Multicenter, Open-label Exploratory Trial to Evaluate the Efficacy, Safety, and Subject Satisfaction With Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2013 to 2014Enrolled61ConditionsMajor Depressive Disorder (MDD)ArmsADT, Brexpiprazole
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
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

6 authors at 2 institutions in 2 countries.

Maurizio FavaMassachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Takao OkameMassachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Yuki MatsushimaMassachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Pamela PerryMassachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Emmanuelle WeillerMassachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Ross A BakerMassachusetts General Hospital, Boston, MA; Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ; H. Lundbeck A/S, Valby, Denmark.
Otsuka (Japan) · JPOtsuka (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Approximately 50% of patients with major depressive disorder do not respond adequately to their antidepressant treatment, underscoring the need for more effective treatment options. The objective of this study was to investigate the effect of adjunctive brexpiprazole on depressive symptoms in patients with major depressive disorder who were not responding to adjunctive or combination therapy of their current antidepressant treatments with several different classes of agents (NCT02012218). Methods: In this 6-week, open-label, phase 3b study, patients with major depressive disorder who had an inadequate response to ≥1 adjunctive or combination therapy, in addition to history of ≥1 failure to monotherapy antidepressant treatment, were switched to adjunctive brexpiprazole. Efficacy was assessed by change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale total score. Patient functioning was assessed using the Sheehan Disability Scale and the Cognitive and Physical Functioning Questionnaire. Safety and tolerability were also assessed. Results: A total of 51/61 (83.6%) patients completed 6 weeks of treatment with adjunctive brexpiprazole. Improvements in depressive symptoms were observed (least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale total score, -17.3 [P < .0001]) as well as improvements in general and cognitive functioning (mean changes from baseline to week 6: Sheehan Disability Scale, -3.1 [P < .0001]; Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire, -9.2 [P < .0001]). The most common adverse event was fatigue (14.8%); akathisia was reported by 8.2% of patients. Conclusions: In patients with major depressive disorder who had switched to open-label adjunctive brexpiprazole following inadequate response to previous adjunctive or combination therapy, improvements were observed in depressive symptoms, general functioning, cognitive function, and energy/alertness.

Indexed as

Antidepressive AgentsAripiprazoleBupropionCentral Nervous System StimulantsCognitionDepressive Disorder, Treatment-ResistantDrug Therapy, CombinationFemaleHumansImpulsive BehaviorMajor Depressive DisorderMaleMiddle AgedPsychiatric Status Rating ScalesQuetiapine FumarateQuinolonesAntidepressive AgentsAripiprazolebrexpiprazoleBupropionCentral Nervous System StimulantsQuetiapine FumarateQuinolonesThiophenesadjunctiveantidepressantbrexpiprazolemajor depressive disorderswitching

Identifiers

PMID27784751
PMCPMC5412581
OpenAlexW2545752575

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.