title: A Prospective Study Comparing the Long-term Effectiveness of Injectable Risperidone Long-acting Therapy and Oral Aripiprazole in Patients with Schizophrenia.
abstract: OBJECTIVE
  To test the hypothesis that long-term maintenance with injectable risperidone long-acting therapy is superior to oral daily aripiprazole in stable patients with schizophrenia.
  
  
  METHODS
  This two-year, rater-blinded, open-label, multicenter study (NCT00299702) randomized subjects to injectable risperidone long-acting therapy (25-50mg, injected every 2 weeks) or oral aripiprazole (5-30mg/day), with study visits every two weeks. Subjects who met relapse criteria or discontinued study drug could remain in the study.
  
  
  METHODS
  Clinical trial.
  
  
  METHODS
  Stable subjects with schizophrenia not adequately benefiting from current treatment who experienced two or more relapses in the past two years. If recently relapsed, subjects were stabilized (per clinician judgment) for two or more months before entry.
  
  
  METHODS
  Primary endpoints: time to relapse and time in remission. Safety assessments included adverse event reporting.
  
  
  RESULTS
  Of 355 subjects randomized, 349 were in the intent-to-treat analysis set. Data inspection revealed that 53 (14.9%) randomized subjects deviated from inclusion/exclusion criteria, most commonly not meeting stability requirements. At baseline, mean (standard deviation [SD]) Positive and Negative Syndrome Scale total score was 68.9 (14.6); 115 (33.0%) intent-to-treat subjects met remission criteria. Approximately 29 percent in each group discontinued the study before completing two years. No significant between-group differences were noted in time to relapse or time in remission. No new tolerability issues were identified.
  
  
  CONCLUSIONS
  RESULTS failed to demonstrate superiority with injectable risperidone long-acting therapy versus oral aripiprazole. The study design did not allow for valid conclusions of equivalence or noninferiority. Although this study attempted to mimic a real-world treatment setting for stable patients, the broad study population, the lack of patient selection for nonadherence, biweekly visits, regular assessments, and other design issues limited generalizability and interpretation relative to the study hypothesis.
authors.affiliation: Dr. Macfadden was with Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey, at the time of this analysis; Dr. Macfadden currently is Medical Director at Princeton Medical Institute, Princeton, New Jersey; Drs. Ma and Haskins are with Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, New Jersey; and Drs. Bossie and Alphs are with Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, New Jersey.
authors.forename: Wayne
authors.initials: W
authors.lastname: Macfadden
authors.forename: Yi-Wen
authors.initials: YW
authors.lastname: Ma
authors.forename: J
authors.initials: J
authors.lastname: Thomas Haskins
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Bossie
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs