title: Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results.
abstract: BACKGROUND
  To evaluate effectiveness outcomes in a real-world setting in patients with schizophrenia initiating risperidone long-acting therapy (RLAT).
  
  
  METHODS
  This was a 24-month, multicenter, prospective, longitudinal, observational study in patients with schizophrenia who were initiated on RLAT. Physicians could change treatment during the study as clinically warranted. Data were collected at baseline and subsequently every 3 months up to 24 months. Effectiveness outcomes included changes in illness severity as measured by Clinical Global Impression-Severity (CGI-S) scale; functional scores as measured by Personal and Social Performance (PSP) scale, Global Assessment of Functioning (GAF), and Strauss-Carpenter Levels of Functioning (LOF); and health status (Medical Outcomes Survey Short Form-36 [SF-36]). Life-table methodology was used to estimate the cumulative probability of relapse over time. Adverse events were evaluated for safety.
  
  
  RESULTS
  532 patients were enrolled in the study; 209 (39.3%) completed the 24-month study and 305 (57.3%) had at least 12 months of follow-up data. The mean (SD) age of patients was 42.3 (12.8) years. Most patients were male (66.4%) and either Caucasian (60.3%) or African American (23.7%). All changes in CGI-S from baseline at each subsequent 3-month follow-up visit were statistically significant (p < .0001), indicating improvement in disease severity. Improvements were also noted for the PSP, GAF, and total LOF, indicating improvement in daily functioning and health outcome.
  
  
  CONCLUSIONS
  Patients with schizophrenia who were initiated on RLAT demonstrated improvements in measures of effectiveness within 3 months, which persisted over 24 months.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00246194.
authors: Ortho McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
authors: Wayne
authors: W
authors: Macfadden
authors: Cherilyn
authors: C
authors: DeSouza
authors: Concetta
authors: C
authors: Crivera
authors: Chris M
authors: CM
authors: Kozma
authors: Riad D
authors: RD
authors: Dirani
authors: Lian
authors: L
authors: Mao
authors: Stephen C
authors: SC
authors: Rodriguez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011788:Quality of Life / Q000523:psychology; D012008:Recurrence; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*
chemical_list: D003692:Delayed-Action Preparations; D018967:Risperidone