Evidence map›Paper›PMID 33761928›Full record

ArticleBMC psychiatry2021

Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia.

Joseph P McEvoy, Peter J Weiden, Paul H Lysaker, Xiaowu Sun, Amy K O'Sullivan

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in BMC psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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
0.6field-weighted citation impact, top 36% 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.

NCT01626456 phase3completednot on this map

A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

TypeinterventionalSponsorAlkermes, Inc.Ran2012 to 2015Enrolled478ConditionsSchizophreniaArmsALKS 9072, Low, ALKS 9072, High
NCT01895452 phase3completednot on this map

A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

TypeinterventionalSponsorAlkermes, Inc.Ran2013 to 2016Enrolled291ConditionsSchizophreniaArmsALKS 9072, Low Dose, ALKS 9072, High Dose
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021
    Pooled it
  2. Trial
  3. Review
  4. 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

5 authors at 3 institutions in 1 country.

Joseph P McEvoyDepartment of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, 997 St. Sebastian Way, EG-1010, Augusta, GA, 30912, USA. JMCEVOY@augusta.edu.
Peter J WeidenAlkermes, Inc., Waltham, MA, USA.
Paul H LysakerRoudebush VA Medical Center, Indianapolis, IN, USA.
Xiaowu SunAlkermes, Inc., Waltham, MA, USA.
Amy K O'SullivanAlkermes, Inc., Waltham, MA, USA.
Alkermes (United States) · USAugusta University · USRichard L. Roudebush VA Medical Center · US

Funding

Alkermes Inc. N/A
6 · The paper itself

Abstract

backgroundThis post hoc analysis of clinical trial data evaluated long-term, self-reported mental and physical health-related quality of life (HRQoL) scores in schizophrenia patients receiving aripiprazole lauroxil (AL), an atypical long-acting injectable (LAI) antipsychotic approved for the treatment of schizophrenia in adults.

methodsThe study population included 291 stable schizophrenia outpatients enrolled in 2 consecutive long-term safety studies of AL given every 4 weeks for up to 124 weeks. HRQoL was measured using the SF-36v2® Health Survey (SF-36v2) over the course of the follow-up. The primary outcome was change in SF-36v2 mental component summary (MCS) and physical component summary (PCS) scores from baseline to 124 weeks. To contextualize these scores, descriptive analyses were conducted to compare the scores with available scores for the general population as well as for other populations with chronic medical (ie, hypertension and type 2 diabetes) or psychiatric (ie, depression) conditions.

resultsResults from this post hoc analysis indicated that the mean MCS score for patients continuing AL improved significantly from baseline over 124 weeks (P < .05, all timepoints), while mean PCS score showed little change over 124 weeks. At baseline, patients had lower (worse) MCS scores than the normed general population, but by week 124, patients had MCS scores comparable to those in the general population. This pattern of change was not observed with PCS scores. Comparison of study MCS scores with those associated with other diseases showed that this schizophrenia cohort had lower scores than those with chronic medical conditions but higher scores than those with depression. PCS scores were higher in the study population than published scores for all reference populations at baseline and week 124.

conclusionsIn this post hoc analysis, outpatients with schizophrenia who continued the LAI antipsychotic AL showed gradual and sustained improvement in self-reported mental HRQoL over several years of follow-up, whereas self-reported physical HRQoL did not change. By the end of follow-up, mental health scores of study patients with schizophrenia were comparable to those of the general population and better than those of patients with depression.

trial registrationClinicalTrials.gov (NCT01626456 [trial registration date: June 15, 2012] and NCT01895452 [trial registration date: July 5, 2013]).

Indexed as

Diabetes Mellitus, Type 2SchizophreniaAdultAripiprazoleHumansQuality of LifeAripiprazolearipiprazole lauroxilAripiprazole lauroxilHealth-related quality of lifeLong-acting injectable antipsychoticsPatient-reported outcomesSchizophreniaSF-36v2

Identifiers

PMID33761928
PMCPMC7992347
OpenAlexW3136370974

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.