title: Health-related quality of life in acute schizophrenia patients treated with RBP-7000 once monthly risperidone: An 8-week, randomized, double-blind, placebo-controlled, multicenter phase 3 study.
abstract: There is increased interest in the impact of new long-acting treatments on health-related quality of life (HRQoL) in patients with schizophrenia. The aim of this study was to evaluate the impact of treatment with subcutaneous injections of RBP-7000, a new sustained-release formulation of risperidone, compared with placebo on health status, subjective well-being, treatment satisfaction, and preference of medicine in subjects with acute schizophrenia.
  
  
  
  HRQoL data were derived from an 8-week double-blind, randomized, placebo-controlled, phase 3 study that assessed efficacy, safety, and tolerability of once monthly RBP-7000 (90mg and 120mg) compared with placebo in subjects with acute schizophrenia (n=337). HRQoL was measured with the EuroQol EQ-5D-5L, well-being using the Neuroleptic Treatment-Short Version (SWN-S), satisfaction using the Medication Satisfaction Questionnaire (MSQ), and preference using the Preference of Medicine Questionnaire (POM).
  
  
  
  The EQ-5D-5L VAS increased significantly in the RBP-7000 120mg group compared to Placebo (p=0.0212). In RBP-7000 120mg, subjects reported significant improvements in SWN-S physical functioning (p=0.0093), social integration (p=0.0368), and total score (p=0.0395). Subjects were significantly more satisfied with RBP-7000 versus placebo (90mg p=0.0009, 120mg p=0.0006) and preferred RBP-7000 over their previous medication (90mg p<0.0001, 120mg p=0.0619).
  
  
  
  Significantly greater improvements in HRQoL and overall well-being were demonstrated in patients randomized to RBP-7000 compared to placebo. The effect was more pronounced in the RBP-7000 120mg group. Patient satisfaction improved significantly and patient preference for their medicine favored RBP-7000 90mg and 120mg versus Placebo.
authors.affiliation: Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States. Electronic address: john.isitt@indivior.com.
authors.forename: John J
authors.initials: JJ
authors.lastname: Isitt
authors.affiliation: Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States.
authors.forename: Vijay R
authors.initials: VR
authors.lastname: Nadipelli
authors.affiliation: Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States.
authors.forename: Alex
authors.initials: A
authors.lastname: Kouassi
authors.affiliation: Massachusetts General Hospital/Harvard Medical School, 55 Fruit Street, Bulfinch 351, Boston, MA 02114, United States.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Fava
authors.affiliation: Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States.
authors.forename: Christian
authors.initials: C
authors.lastname: Heidbreder
mesh_terms: D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D018967:Risperidone / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone
keywords: Antipsychotic agents; Health-related quality of life; Randomized controlled trials; Schizophrenia