Evidence map›Paper›PMID 32087718›Full record

ArticleBMC psychiatry2020

The use of long-acting Aripiprazole in a multi-center, prospective, uncontrolled, open-label, cohort study in Germany: a report on global assessment of functioning and the WHO wellbeing index.

Daniel Schöttle, Wolfgang Janetzky, Daniel Luedecke, Elmar Beck, Christoph U Correll, Klaus Wiedemann

Abstract readMulticenter Study
In one paragraph

Article in BMC psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

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

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Review
  7. Observational
  8. Article
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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.

Daniel SchöttleKlinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany. d.schoettle@uke.de.ORCID 0000-0002-8589-727X
Wolfgang JanetzkyLundbeck GmbH, Ericusspitze 2, 20457, Hamburg, Germany.
Daniel LuedeckeKlinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Elmar BeckANFOMED GmbH, Röttenbacher Str. 17, 91096 Möhrendorf, Hamburg, Germany.
Christoph U CorrellThe Zucker Hillside Hospital, Department of Psychiatry, Hofstra Northwell School of Medicine, Northwell Health, 75-59 263rd St, Glen Oaks, NY, 11004, USA.
Klaus WiedemannKlinik für Psychiatrie und Psychotherapie, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this non-interventional study, the functionality and well-being of patients with schizophrenia with aripiprazole once-monthly (AOM) was evaluated under real-life conditions in a naturalistic population.

methodsThis non-interventional, prospective, multicenter 6-month study included 242 predominantly symptomatically stable patients (mean age 43.1 ± 15.1 years, 55% male) who switched their treatment to AOM after 9.7 (± 22.3) months of oral treatment. Outcome parameters included functionality (Global Assessment of Functioning, GAF), patient's wellbeing (WHO-5 Well-Being Index, WHO-5), and both patient's and clinician's assessment of efficacy and tolerability of AOM. Treatment emergent adverse events (TRAE) were also recorded.

resultsAt baseline, the mean GAF score was 47.0 (±13.9), indicating that patients experienced serious impairment in functioning. A continuous increase to 60.2 (±17.0) during treatment was found, with a robust and significant increase already after 4 weeks. At study start, patients reported diminished wellbeing, with a mean score of 10.6 (±5.6) on the WHO-5 scale. During treatment, patient wellbeing increased continuously with strong and significant improvements even after 4 weeks and an overall improvement of 4.8 (±6.9) over the course of 6 months with an endpoint of 15.4 (±5.5). Stratification of these results showed that more pronounced effects were achieved in younger patients ≤35 years (p<0.05 for GAF). The effectiveness and tolerability of AOM was rated good/very good by most patients (89.2 and 93.7%) and physicians (91.4 and 96.8%). Only few TRAEs occurred.

conclusionsOur results show a significant positive effect after initiation of AOM treatment in predominantly stable patients with schizophrenia on their functioning and wellbeing, which was even more pronounced in patients aged ≤35 years, thereby supporting previous randomized controlled findings under routine conditions in clinical practice.

Indexed as

Antipsychotic AgentsAdultAripiprazoleCohort StudiesFemaleGermanyHumansMaleMiddle AgedProspective StudiesTreatment OutcomeWorld Health OrganizationAntipsychotic AgentsAripiprazoleLAILong-acting injectableNaturalisticPatient perspectiveSchizoaffectiveSchizophrenia

Identifiers

PMID32087718
PMCPMC7035668

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Registered trials

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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.