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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT00044655.

• Authors: Nancy H Covell, Joseph P McEvoy, Nina R Schooler, T Scott Stroup, Carlos T Jackson, Ingrid A Rojas, Susan M Essock, Schizophrenia Trials Network
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 73 Issue 5 Pg. 669-75 (May 2012) ISSN: 1555-2101 [Electronic] United States
• PMID: 22480442 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: © Copyright 2012 Physicians Postgraduate Press, Inc.

Chemical References

• Antipsychotic Agents
• Delayed-Action Preparations
• haloperidol decanoate
• Haloperidol
• Risperidone
• Fluphenazine

Topics

• Antipsychotic Agents (administration & dosage, adverse effects)
• Connecticut
• Delayed-Action Preparations
• Drug Substitution
• Female
• Fluphenazine (administration & dosage, adverse effects)
• Follow-Up Studies
• Haloperidol (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Hyperprolactinemia (chemically induced)
• Injections
• Intention to Treat Analysis
• Kaplan-Meier Estimate
• Male
• Microspheres
• Middle Aged
• Patient Compliance
• Proportional Hazards Models
• Risperidone (administration & dosage, adverse effects)
• Schizophrenia (drug therapy)
• Weight Gain