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- Title
LURASIDONE IN THE LONG-TERM TREATMENT OF PATIENTS WITH BIPOLAR DISORDER: A 24-WEEK OPEN-LABEL EXTENSION STUDY.
- Authors
Ketter, Terence A.; Sarma, Kaushik; Silva, Robert; Kroger, Hans; Cucchiaro, Josephine; Loebel, Antony
- Abstract
<bold>Background: </bold>The aim of this study was to evaluate the safety and tolerability of 6 months of open-label, uncontrolled extension treatment with lurasidone in patients with a diagnosis of bipolar depression who completed 6 weeks of acute treatment.<bold>Methods: </bold>Patients completing 6 weeks of double-blind placebo-controlled treatment with either lurasidone monotherapy (one study) or adjunctive therapy with lithium or valproate (two studies), were treated for 6 months with flexible doses of lurasidone, 20-120 mg/day, in an open-label, uncontrolled extension study (N = 813; monotherapy, 38.9%; adjunctive therapy, 61.1%). Changes in safety parameters were calculated from double-blind, acute-phase baseline to month 6 of the extension phase, using a last observation carried forward (LOCF endpoint) analysis.<bold>Results: </bold>Five hundred fifty-nine of 817 (68.4%) patients completed the extension study. In the monotherapy and adjunctive therapy groups, 6.9 and 9.0%, respectively, discontinued due to an adverse event. For the monotherapy and adjunctive therapy groups, respectively, changes from double-blind baseline to month 6 were +0.8 and +0.9 kg for weight (mean), 0.0 and +2.0 mg/dL for total cholesterol (median), +5.0 and +5.0 mg/dL for triglycerides (median), -1.0 and 0.0 mg/dL for glucose (median); -22.6 and -21.7 for Montgomery-Asberg Depression Rating Scale (MADRS; mean); whereas change from open-label baseline to month 6 were +0.85 and +0.88 kg for weight (mean), and -6.9 and -6.5 for MADRS (mean).<bold>Conclusions: </bold>Six months of treatment with open-label lurasidone was safe and well tolerated with minimal effect on weight and metabolic parameters; continued improvement in depressive symptoms was observed.
- Subjects
BIPOLAR disorder; THERAPEUTICS; DRUG dosage; DIAGNOSIS of bipolar disorder; DRUG tolerance; MEDICATION safety; PATIENTS; LITHIUM compounds; ANTIPSYCHOTIC agents; STATISTICAL sampling; TIME; VALPROIC acid; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment
- Publication
Depression & Anxiety (1091-4269), 2016, Vol 33, Issue 5, p424
- ISSN
1091-4269
- Publication type
journal article
- DOI
10.1002/da.22479