Evidence map›Paper›PMID 27571460›Full record

Trial reportInternational clinical psychopharmacology2016

The effect of brexpiprazole in adult outpatients with early-episode schizophrenia: an exploratory study.

Ashok Malla, Ai Ota, Kazuhiro Nagamizu, Pamela Perry, Emmanuelle Weiller, Ross A Baker

Abstract readClinical Trial
In one paragraph

Trial report in International clinical psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021
    Pooled it
  2. Article
  3. Article
  4. Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents.Tremor and other hyperkinetic movements (New York, N.Y.) · 2022
    Review
  5. 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.

Ashok MallaaDepartment of Psychiatry, McGill University, Montreal, Quebec, Canada bOtsuka Pharmaceutical Co., Tokyo, Japan cOtsuka Pharmaceutical Development & Commercialization Inc., Princeton, New Jersey, USA dH. Lundbeck A/S, Valby, Denmark.
Ai Ota
Kazuhiro Nagamizu
Pamela Perry
Emmanuelle Weiller
Ross A Baker

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to evaluate flexibly dosed brexpiprazole for early-episode schizophrenia through the assessment of efficacy, social functioning, and tolerability. This was an exploratory, 16-week, open-label, flexible-dose (1, 2, 3, or 4 mg/day; target dose 3 mg/day) study in outpatients with early-episode schizophrenia (18-35 years old, ≤5 years' duration of illness). Efficacy was assessed by the Positive and Negative Syndrome Scale score (PANSS) and social functioning was assessed by changes from baseline in PANSS modified prosocial subscale, personal and social performance (PSP), and specific levels of functioning (SLOF) scales. Safety and tolerability were also evaluated. Overall, 25/49 patients completed the study. Symptoms of schizophrenia improved over the entire treatment period, as evidenced by reductions in PANSS total score from baseline (least squares mean change at week 16: -10.2). Improvements in social functioning were shown by least squares mean changes from baseline at week 16 in the PANSS prosocial subscale (-2.0), PSP (6.6), and SLOF (13.1). Brexpiprazole was generally well tolerated; the most common adverse events were insomnia (7/49 patients), somnolence (4/49), sedation, weight increase, and nausea (each 3/49). Brexpiprazole may represent a novel and effective treatment strategy for patients with early-episode schizophrenia and may be effective for improving social function.

Indexed as

AdultAmbulatory CareAntipsychotic AgentsDose-Response Relationship, DrugEarly DiagnosisFemaleFollow-Up StudiesHumansMaleOutpatientsQuinolonesSchizophreniaSerotonin AgentsThiophenesTreatment OutcomeYoung AdultAntipsychotic AgentsbrexpiprazoleQuinolonesSerotonin AgentsThiophenes

Identifiers

PMID27571460
PMCPMC5049948

What OpenQuestion holds

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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.