title: Long-term safety and tolerability of aripiprazole once-monthly in maintenance treatment of patients with schizophrenia.
abstract: The aim of this study was to evaluate the safety and tolerability of aripiprazole once-monthly (ARI-OM) for the maintenance treatment of schizophrenia. This long-term, pivotal study had four phases: oral conversion (phase 1, 4-6 weeks); oral stabilization (phase 2, 4-12 weeks); ARI-OM stabilization with coadministration of oral aripiprazole in the first 2 weeks (phase 3, 12-36 weeks); and a 52-week, randomized [phase 4, ARI-OM vs. placebo (2 : 1)], double-blind, maintenance phase. Safety was assessed across study phases by the time of first onset of adverse events, as were objective measures of extrapyramidal symptoms, fasting metabolic parameters, and body weight. Patient enrollment was phase 1=633; phase 2=710, of whom 210 entered phase 2 directly; phase 3=576; and phase 4=403 (ARI-OM, n=269; placebo, n=134). Adverse events (>5%) in any phase were insomnia, headache, anxiety, akathisia, increase in weight, injection-site pain, and tremor. Headache, somnolence, and nausea had a peak first onset within 4 weeks of treatment initiation. The incidence of extrapyramidal symptoms was similar in all phases. There were no unexpected changes in weight or shifts in fasting metabolic parameters across all study phases. ARI-OM had a safety and tolerability profile comparable with oral aripiprazole in maintenance treatment of schizophrenia.
authors.affiliation: Department of Psychiatry and Psychotherapy, Division of Biological Psychiatry, Medical University Innsbruck, Innsbruck, Austria. wolfgang.fleischhacker@i-med.ac.at
authors.forename: W Wolfgang
authors.initials: WW
authors.lastname: Fleischhacker
authors.forename: Raymond
authors.initials: R
authors.lastname: Sanchez
authors.forename: Brian
authors.initials: B
authors.lastname: Johnson
authors.forename: Na
authors.initials: N
authors.lastname: Jin
authors.forename: Robert A
authors.initials: RA
authors.lastname: Forbes
authors.forename: Robert
authors.initials: R
authors.lastname: McQuade
authors.forename: Ross A
authors.initials: RA
authors.lastname: Baker
authors.forename: William
authors.initials: W
authors.lastname: Carson
authors.forename: John M
authors.initials: JM
authors.lastname: Kane
mesh_terms: D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000068180:Aripiprazole; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D006801:Humans; D015994:Incidence; D007273:Injections, Intramuscular; D060046:Maintenance Chemotherapy / Q000009:adverse effects; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole