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LURASIDONE IN THE LONG‐TERM TREATMENT OF PATIENTS WITH BIPOLAR DISORDER: A 24‐WEEK OPEN‐LABEL EXTENSION STUDY
| Content Provider | Scilit |
|---|---|
| Author | Ketter, Terence A. Sarma, Kaushik Silva, Robert Kroger, Hans Cucchiaro, Josephine Loebel, Antony |
| Copyright Year | 2016 |
| Description | Journal: Depression and Anxiety 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. 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. 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). 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. |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5069590/pdf |
| Ending Page | 434 |
| Page Count | 11 |
| Starting Page | 424 |
| e-ISSN | 15206394 |
| DOI | 10.1002/da.22479 |
| Journal | Depression and Anxiety |
| Issue Number | 5 |
| Volume Number | 33 |
| Language | English |
| Publisher | Wiley-Blackwell |
| Publisher Date | 2016-02-26 |
| Access Restriction | Open |
| Subject Keyword | Journal: Depression and Anxiety Psychiatry and Mental Health Bipolar Disorder Bipolar Depression Antipsychotic Agents Depressive Disorder Major Depression |
| Content Type | Text |
| Resource Type | Article |
