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 Patrick McEvoy, Nina R. Schooler, T. Scott Stroup, Carlos T. Jackson, Ingrid A. Rojas, Susan M. Essock

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Objective: This multisite randomized trial addressed risks and benefits of staying on long-acting injectable haloperidol or fluphenazine versus switching to long-acting injectable risperidone microspheres. Method: From 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. Results: Groups 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. Conclusion: Switching 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.

Original languageEnglish (US)
Pages (from-to)669-675
Number of pages7
JournalJournal of Clinical Psychiatry
Volume73
Issue number5
DOIs
StatePublished - Jan 1 2012

Fingerprint

Risperidone
Microspheres
Randomized Controlled Trials
Injections
Prolactin
Body Mass Index
Fluphenazine
Haloperidol
Therapeutics
Clinical Protocols
Psychopathology
Diagnostic and Statistical Manual of Mental Disorders
Psychotic Disorders
Weight Gain
Schizophrenia
Hospitalization
Outpatients
Regression Analysis
Interviews
fluphenazine depot

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres : An open-label, randomized controlled trial. / Covell, Nancy H.; McEvoy, Joseph Patrick; Schooler, Nina R.; Stroup, T. Scott; Jackson, Carlos T.; Rojas, Ingrid A.; Essock, Susan M.

In: Journal of Clinical Psychiatry, Vol. 73, No. 5, 01.01.2012, p. 669-675.

Research output: Contribution to journalArticle

@article{09369bf864064a209aa47e7e506b449e,
title = "Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres: An open-label, randomized controlled trial",
abstract = "Objective: This multisite randomized trial addressed risks and benefits of staying on long-acting injectable haloperidol or fluphenazine versus switching to long-acting injectable risperidone microspheres. Method: From 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. Results: Groups 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. Conclusion: Switching 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.",
author = "Covell, {Nancy H.} and McEvoy, {Joseph Patrick} and Schooler, {Nina R.} and Stroup, {T. Scott} and Jackson, {Carlos T.} and Rojas, {Ingrid A.} and Essock, {Susan M.}",
year = "2012",
month = "1",
day = "1",
doi = "10.4088/JCP.11m07074",
language = "English (US)",
volume = "73",
pages = "669--675",
journal = "Journal of Clinical Psychiatry",
issn = "0160-6689",
publisher = "Physicians Postgraduate Press Inc.",
number = "5",

}

TY - JOUR

T1 - Effectiveness of switching from long-acting injectable fluphenazine or haloperidol decanoate to long-acting injectable risperidone microspheres

T2 - An open-label, randomized controlled trial

AU - Covell, Nancy H.

AU - McEvoy, Joseph Patrick

AU - Schooler, Nina R.

AU - Stroup, T. Scott

AU - Jackson, Carlos T.

AU - Rojas, Ingrid A.

AU - Essock, Susan M.

PY - 2012/1/1

Y1 - 2012/1/1

N2 - Objective: This multisite randomized trial addressed risks and benefits of staying on long-acting injectable haloperidol or fluphenazine versus switching to long-acting injectable risperidone microspheres. Method: From 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. Results: Groups 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. Conclusion: Switching 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.

AB - Objective: This multisite randomized trial addressed risks and benefits of staying on long-acting injectable haloperidol or fluphenazine versus switching to long-acting injectable risperidone microspheres. Method: From 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. Results: Groups 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. Conclusion: Switching 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.

UR - http://www.scopus.com/inward/record.url?scp=84861831352&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84861831352&partnerID=8YFLogxK

U2 - 10.4088/JCP.11m07074

DO - 10.4088/JCP.11m07074

M3 - Article

C2 - 22480442

AN - SCOPUS:84861831352

VL - 73

SP - 669

EP - 675

JO - Journal of Clinical Psychiatry

JF - Journal of Clinical Psychiatry

SN - 0160-6689

IS - 5

ER -