title: Effect of lurasidone on meaningful change in health-related quality of life in patients with bipolar depression.
abstract: Estimate the proportion of lurasidone-treated patients with bipolar depression who achieved a clinically meaningful improvement in health-related quality of life (HRQoL) as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). A post-hoc analysis of data from two 6-week, randomized, placebo-controlled clinical trials of lurasidone as monotherapy (20-60 or 80-120 mg/day) or adjunctive therapy (20-120 mg/day) was carried out. The proportion of patients with clinically meaningful HRQoL improvement at 6 weeks was assessed using the following methods: an anchor-based method using a one-point improvement on the Clinical Global Impression-Severity, Bipolar Version (CGI-BP-S) scale; a distribution-based method using Q-LES-Q SF's SEM; and cumulative distribution functions. Data from 364 and 275 patients were available from the monotherapy and adjunctive therapy trials, respectively. Using anchor-based thresholds, a significantly higher proportion of lurasidone-treated patients reported a clinically meaningful improvement in HRQoL versus placebo in monotherapy (65.0% and 62.5 vs. 41.1%, both P<0.01) and adjunctive therapy (65.2 vs. 50.7%, P<0.05). Similar findings were observed using distribution-based thresholds for monotherapy (82.5% and 78.3 vs. 58.1%, both P<0.01) and adjunctive therapy (74.5 vs. 62.7%, P<0.05), and through the visual display of cumulative distribution functions. Short-term lurasidone monotherapy and adjunctive therapy is associated with a clinically meaningful improvement in HRQoL in patients with bipolar depression.
authors.affiliation: aBipolar Disorders Research Center, Cleveland, Ohio bHealth Economics and Outcomes Research, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts cOutcomes Research, Evidera, Bethesda, Maryland dResearch and Development, Sunovion Pharmaceuticals Inc., Fort Lee, New Jersey, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Calabrese
authors.forename: Krithika
authors.initials: K
authors.lastname: Rajagopalan
authors.forename: Daisy
authors.initials: D
authors.lastname: Ng-Mak
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Bacci
authors.forename: Kathy
authors.initials: K
authors.lastname: Wyrwich
authors.forename: Andrei
authors.initials: A
authors.lastname: Pikalov
authors.forename: Antony
authors.initials: A
authors.lastname: Loebel
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008094:Lithium / Q000627:therapeutic use; D000069056:Lurasidone Hydrochloride / Q000627:therapeutic use*; D008297:Male; D011788:Quality of Life; D014635:Valproic Acid / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D014635:Valproic Acid; D008094:Lithium; D000069056:Lurasidone Hydrochloride