Evidence map›Paper›PMID 30991969›Full record

ArticleBMC psychiatry2019

Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study.

Sally Mustafa, Joanna Bougie, Maia Miguelez, Guerline Clerzius, Emmanouil Rampakakis, Jean Proulx, Ashok Malla

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in BMC psychiatry, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02131415 (Canadian Non-Interventional Prospective Cohort Study on the Real - Life Assessment of Abilify Maintena ™ in Schizophrenia), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT02131415 terminatednot on this map

Canadian Non-Interventional Prospective Cohort Study on the Real - Life Assessment of Abilify Maintena ™ in Schizophrenia

TypeobservationalSponsorLundbeck Canada Inc.Ran2014 to 2017Enrolled200ConditionsSchizophrenia
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Observational
  3. Observational
  4. Article
  5. Effectiveness of Switching to Long-acting Injectable Aripiprazole in Patients with Recent-onset and Chronic Schizophrenia.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2023
    Article
  6. Article
  7. Article
  8. Real-world effectiveness of aripiprazole once-monthly REACT study: Pooled analysis of two noninterventional studies.European psychiatry : the journal of the Association of European Psychiatrists · 2022
    Article
  9. Article
  10. Observational
  11. 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.

Sally MustafaDouglas Mental Health University Institute, Montreal, Quebec, Canada.
Joanna BougieLundbeck Canada Inc, Montreal, Quebec, Canada.
Maia MiguelezOtsuka Canada Pharmaceutical Inc, Montreal, Quebec, Canada.
Guerline ClerziusLundbeck Canada Inc, Montreal, Quebec, Canada.
Emmanouil RampakakisJSS Medical Research, Montreal, Quebec, Canada.
Jean ProulxLundbeck Canada Inc, Montreal, Quebec, Canada.
Ashok MallaDouglas Mental Health University Institute, Montreal, Quebec, Canada. ashok.malla@mcgill.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWith previously established efficacy of aripiprazole once-monthly injectable formulation (AOM) in pre-registration randomized controlled trials, the current study was designed to evaluate its effectiveness in patients treated for schizophrenia in regular clinical settings in Canada.

methodsFollowing their clinicians' decision to prescribe AOM, 193 patients with a diagnosis of schizophrenia, were recruited from 17 Canadian community or hospital-based settings. The primary outcome of global functioning was assessed with the Global Assessment of Functioning Scale (GAF) at 3-month intervals for 1 year. Secondary outcomes (social and occupational functioning and illness severity) and adverse drug reactions (ADR) were also assessed.

resultsA majority of the 169 evaluable patients were within the first 5 years of diagnosis (early phase). A linear mixed model analysis showed a significant main effect of time (Type III test p < 0.001) after adjusting for baseline GAF score, with a change in mean GAF scores from 49 at baseline to 61 at 12 months. No differences between early vs late phase were observed. Results on secondary outcome measures of function (Social and Occupational Functioning Scale) and illness severity (Clinical Global Impression-Severity Scale and Brief Psychiatric Rating Scale) were similar. Serious ADRs were observed in 29 (14.6%) patients and akathisia in 18 (9.1%) patients. At month-12, significant (≥7%) weight gain was observed in 25.7% (n = 27/105) of patients.

conclusionsTreatment with AOM is effective in improving symptoms and functioning in schizophrenia patients treated in regular clinical settings. Akathisia was infrequent while one quarter of patients gained clinically significant weight.

trial registrationUnique identifier: NCT02131415 . First posted: 06 May 2014.

Indexed as

Antipsychotic AgentsAripiprazoleSchizophreniaSchizophrenic PsychologyAdolescentAdultBrief Psychiatric Rating ScaleCanadaCohort StudiesDrug Administration ScheduleFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesAntipsychotic AgentsAripiprazoleAdherenceAripiprazole once-monthlyGlobal functioningLong acting injectable antipsychoticsSchizophrenia

Identifiers

PMID30991969
PMCPMC6469112

What OpenQuestion holds

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LicenceCC BY
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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.