Martha Sajatovic 1,2 , Brent P Forester 3 , Joyce Tsai 4 , Hans Kroger 4 , Andrei Pikalov 4 , Josephine Cucchiaro 4 , Antony Loebel 4 Show Affiliations »
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OBJECTIVE: The aim of this post hoc analysis was to evaluate the efficacy of lurasidone in patients aged 55 years and older with bipolar depression . METHODS: A post hoc analysis was performed on the older adult subgroup (n = 142) of outpatients meeting DSM-IV-TR criteria for bipolar I depression in 2 placebo -controlled, 6-week, randomized, double-blind studies conducted from 2009-2012 : a monotherapy study comparing fixed flexible-dose ranges of lurasidone 20-60 mg/d or 80-120 mg/d with placebo and an adjunctive therapy study comparing flexible doses of lurasidone 20-120 mg/d with placebo adjunctive to either lithium or valproate . The primary endpoint was mean change at week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score . RESULTS: In the randomized sample, the proportion of older adults was 88/505 (17.4%) in the monotherapy study and 54/348 (15.5%) in the adjunctive therapy study . In the older adult subgroup in the monotherapy study, mean change at week 6 in the MADRS was significantly greater for lurasidone versus placebo (-14.8 vs -7.1; P = .003; effect size, 0.83; pooled doses), and in the adjunctive therapy study, mean change for lurasidone was not significantly different from placebo (-13.9 vs -11.1; P = .398; effect size, 0.26). Discontinuation rates due to adverse events for lurasidone versus placebo were similar for the monotherapy (6.8% vs 6.9%) and adjunctive therapy (3.8% vs 7.1%) studies. Lurasidone had minimal effects on metabolic laboratory values . CONCLUSIONS: The results of these post hoc analyses, which assessed the efficacy of lurasidone in older adults with bipolar disorder , found that monotherapy was significantly effective while adjunctive therapy was not associated with significant improvement. Both monotherapy and adjunctive therapy with lurasidone were safe and well-tolerated in this older adult population . TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00868699, NCT00868452. © Copyright 2016 Physicians Postgraduate Press, Inc.
RCT Entities: Population
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OBJECTIVE: The aim of this post hoc analysis was to evaluate the efficacy of lurasidone in patients aged 55 years and older with bipolar depression . METHODS: A post hoc analysis was performed on the older adult subgroup (n = 142) of outpatients meeting DSM-IV-TR criteria for bipolar I depression in 2 placebo-controlled, 6-week, randomized, double-blind studies conducted from 2009-2012: a monotherapy study comparing fixed flexible-dose ranges of lurasidone 20-60 mg/d or 80-120 mg/d with placebo and an adjunctive therapy study comparing flexible doses of lurasidone 20-120 mg/d with placebo adjunctive to either lithium or valproate . The primary endpoint was mean change at week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. RESULTS: In the randomized sample, the proportion of older adults was 88/505 (17.4%) in the monotherapy study and 54/348 (15.5%) in the adjunctive therapy study. In the older adult subgroup in the monotherapy study, mean change at week 6 in the MADRS was significantly greater for lurasidone versus placebo (-14.8 vs -7.1; P = .003; effect size, 0.83; pooled doses), and in the adjunctive therapy study, mean change for lurasidone was not significantly different from placebo (-13.9 vs -11.1; P = .398; effect size, 0.26). Discontinuation rates due to adverse events for lurasidone versus placebo were similar for the monotherapy (6.8% vs 6.9%) and adjunctive therapy (3.8% vs 7.1%) studies. Lurasidone had minimal effects on metabolic laboratory values. CONCLUSIONS: The results of these post hoc analyses, which assessed the efficacy of lurasidone in older adults with bipolar disorder , found that monotherapy was significantly effective while adjunctive therapy was not associated with significant improvement. Both monotherapy and adjunctive therapy with lurasidone were safe and well-tolerated in this older adult population. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00868699, NCT00868452. © Copyright 2016 Physicians Postgraduate Press, Inc.
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Year: 2016
PMID： 27529375 DOI： 10.4088/JCP.15m10261
Source DB: PubMed Journal: J Clin Psychiatry ISSN： 0160-6689 Impact factor: 4.384