Evidence map›Paper›PMID 22480442›Full record

Trial reportThe Journal of clinical psychiatry2012

Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres: an open-label, randomized controlled trial.

Nancy H Covell, Joseph P McEvoy, Nina R Schooler, T Scott Stroup, Carlos T Jackson, Ingrid A Rojas, Susan M Essock, Schizophrenia Trials Network

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00044655 (Effectiveness of Switching Antipsychotic Medications), which is not on this map. Cited by 18 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 5 pooled it
3.4field-weighted citation impact, top 8% 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.

NCT00044655 phase4completednot on this map

Effectiveness of Switching Antipsychotic Medications

TypeinterventionalSponsorIcahn School of Medicine at Mount SinaiRan2001 to 2009Enrolled219ConditionsSchizophreniaArmsRisperidone, Olanzapine, Ziprasidone, Quetiapine, Aripiprazole
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 5 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  3. Haloperidol discontinuation for people with schizophrenia.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Risperidone (depot) for schizophrenia.The Cochrane database of systematic reviews · 2016
    Pooled it
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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

8 authors at 4 institutions in 1 country.

Nancy H CovellNew York State Psychiatric Institute, New York, NY 10032, USA. covelln@nyspi.columbia.edu
Joseph P McEvoy
Nina R Schooler
T Scott Stroup
Carlos T Jackson
Ingrid A Rojas
Susan M Essock
Schizophrenia Trials Network
Columbia University · USCenter for Health and Learning · USGeorgetown University · USNew York State Psychiatric Institute

Funding

PUBLIC EDUCATION CAMPAIGN ON DEPRESSION DARTN01MH090001 · NIMH · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · 1989 to 2003
$10.4M
EFFECTIVENESS OF SWITCHING: CONVENTIONALS TO ATYPICALSR01MH059312 · NIMH · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI ESSOCK, SUSAN M · 2001 to 2003
$4.5M
Changing from Conventional to Risperidone DecanoateR03MH071663 · NIMH · UNIVERSITY OF CONNECTICUT STORRS · PI COVELL, NANCY H · 2004 to 2005
$148k
Pop-Track NIMHZ01MH900001 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI POP-TRACK, IC · 2002 to 2003
–
NIMH NIH HHS MH59312NIMH NIH HHS MH71663NIMH NIH HHS MH900001NIMH NIH HHS N01 MH090001NIMH NIH HHS R01 MH059312NIMH NIH HHS R03 MH071663
6 · The paper itself

Abstract

objectiveThis multisite randomized trial addressed risks and benefits of staying on long-acting injectable haloperidol or fluphenazine versus switching to long-acting injectable risperidone microspheres.

methodFrom December 2004 through March 2008, adult outpatients with a Structured Clinical Interview for DSM-IV Axis I Disorders-Patient Edition diagnosis of schizophrenia or schizoaffective disorder who were taking haloperidol decanoate (n = 40) or fluphenazine decanoate (n = 22) were randomly assigned to stay on current long-acting injectable medication or switch to risperidone microspheres and followed for 6 months under study protocol and an additional 6 months naturalistic follow-up. Kaplan-Meier and Cox regression analyses were used to examine the primary outcome (time to treatment discontinuation), and random regression models were used to examine secondary outcomes.

resultsGroups did not differ significantly in time to treatment discontinuation through 6 months of protocol-driven treatment. When the 6-month naturalistic follow-up period was included, time to treatment discontinuation was significantly shorter for individuals assigned to switch than for individuals assigned to stay (10% of stayers discontinued versus 31% of switchers; P = .01). Groups did not differ with respect to psychopathology, hospitalizations, sexual side effects, new-onset tardive dyskinesia, or new-onset extrapyramidal symptoms. However, those randomized to switch to long-acting injectable risperidone microspheres had greater increases in body mass (increase of 1.0 body mass index [BMI] versus decrease of -0.3 BMI; P = .00) and prolactin (maximum increase to 23.4 ng/mL versus decrease to 15.2 ng/mL, P = .01) compared to those randomized to stay.

conclusionSwitching from haloperidol decanoate or fluphenazine decanoate to risperidone microspheres resulted in more frequent treatment discontinuation as well as significant weight gain and increases in prolactin.

trial registrationClinicalTrials.gov identifier: NCT00044655.

Indexed as

Drug SubstitutionMicrospheresAntipsychotic AgentsConnecticutDelayed-Action PreparationsFemaleFluphenazineFollow-Up StudiesHaloperidolHumansHyperprolactinemiaInjectionsIntention to Treat AnalysisKaplan-Meier EstimateMaleMiddle AgedAntipsychotic AgentsDelayed-Action PreparationsFluphenazineHaloperidolhaloperidol decanoateRisperidone

Identifiers

PMID22480442
PMCPMC3739692
OpenAlexW2010248094

What OpenQuestion holds

Textmetadata
LicenceTDM
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.