Evidence map›Paper›PMID 31616148›Full record

ArticleNeuropsychiatric disease and treatment2019

Use of the Functioning Assessment Short Test (FAST) in defining functional recovery in bipolar I disorder. Post-hoc analyses of long-term studies of aripiprazole once monthly as maintenance treatment.

Jessica Madera, Pedro Such, Peter Zhang, Ross A Baker, Iria Grande

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

Article in Neuropsychiatric disease and treatment, 2019. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 38% 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.

NCT01567527 phase3completednot on this map

52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2012 to 2016Enrolled731ConditionsBipolar I DisorderArmsIntramuscular (IM) Depot Aripiprazole, Intramuscular (IM) Depot Placebo
NCT01710709 phase3completednot on this map

A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2012 to 2016Enrolled748ConditionsBipolar IArmsAripiprazole
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. 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

5 authors at 3 institutions in 3 countries.

Jessica MaderaMedical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, NJ, USA.
Pedro SuchMedical Affairs, H. Lundbeck A/S, Valby, Denmark.
Peter ZhangMedical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, NJ, USA.
Ross A BakerMedical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, NJ, USA.
Iria GrandeBipolar and Depression Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
Otsuka (United States) · USConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESLundbeck (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThere is growing agreement that definitions of "recovery" in bipolar-I disorder (BP-I) should include functional outcomes beyond sustained symptomatic remission. In this post-hoc analysis, we assessed functional recovery rates according to the validated Functioning Assessment Short Test (FAST) in participants with BP-I after 52 weeks of maintenance treatment with aripiprazole once monthly (AOM). PATIENTS AND

methodsRates of functional recovery with AOM 400 were investigated in two 52-week studies. NCT01567527 was a placebo-controlled, double-blind, randomized-withdrawal study and NCT01710709 was an open-label study. Functional recovery, assessed at the end of the respective maintenance phases, was defined as a total FAST score of ≤11 for 8 consecutive weeks.

resultsPost-hoc analyses included 229 patients from the randomized-withdrawal study (AOM 400 n=116; placebo n=113). The open-label study included 402 patients (including 321 de novo patients and 81 rollover patients who had completed the randomized-withdrawal study). In the randomized-withdrawal study, functional recovery was achieved by 30.2% (n=35) of the AOM 400 group compared with 24.8% (n=28) in the placebo group. The difference was not statistically significant (

conclusionThese data highlight the utility of a sustained FAST total score of ≤11 as a definition of recovery and emphasize the possibility of achieving this ambitious treatment goal with effective long-term treatment.

Indexed as

aripiprazolebipolar disorderfunctioninglong-acting injectablemaintenancerecovery

Identifiers

PMID31616148
PMCPMC6699506
OpenAlexW2968769916

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.