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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00044655.
authors.affiliation: New York State Psychiatric Institute, New York, NY 10032, USA. covelln@nyspi.columbia.edu
authors.forename: Nancy H
authors.initials: NH
authors.lastname: Covell
authors.forename: Joseph P
authors.initials: JP
authors.lastname: McEvoy
authors.forename: Nina R
authors.initials: NR
authors.lastname: Schooler
authors.forename: T Scott
authors.initials: TS
authors.lastname: Stroup
authors.forename: Carlos T
authors.initials: CT
authors.lastname: Jackson
authors.forename: Ingrid A
authors.initials: IA
authors.lastname: Rojas
authors.forename: Susan M
authors.initials: SM
authors.lastname: Essock
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003237:Connecticut; D003692:Delayed-Action Preparations; D057915:Drug Substitution; D005260:Female; D005476:Fluphenazine / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D006966:Hyperprolactinemia / Q000139:chemically induced; D007267:Injections; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D010349:Patient Compliance; D016016:Proportional Hazards Models; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects; D012559:Schizophrenia / Q000188:drug therapy*; D015430:Weight Gain
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; C033563:haloperidol decanoate; D006220:Haloperidol; D018967:Risperidone; D005476:Fluphenazine