Double-Blind, Placebo-Controlled Study of Lurasidone Monotherapy for the Treatment of Bipolar I Depression
| العنوان: | Double-Blind, Placebo-Controlled Study of Lurasidone Monotherapy for the Treatment of Bipolar I Depression |
|---|---|
| المؤلفون: | Mari Miyajima, Kei Watabe, Jun Ishigooka, Teruhiko Higuchi, Tadafumi Kato, Eduard Vieta, Takahiro Masuda, Tomohiro Fujimori |
| المصدر: | Psychiatry and Clinical Neurosciences Dipòsit Digital de la UB Universidad de Barcelona |
| بيانات النشر: | Wiley, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, Bipolar Disorder, Philippines, Placebo-controlled study, Akathisia, Russia, Lurasidone Hydrochloride, 0302 clinical medicine, depressive disorder, Japan, Outcome Assessment, Health Care, Manic-depressive illness, Administration of drugs, Trastorn bipolar, General Neuroscience, Regular Article, antipsychotic agents, General Medicine, Middle Aged, Psychiatry and Mental health, Neurology, Female, Administració de medicaments, medicine.symptom, medicine.drug, Adult, Slovakia, medicine.medical_specialty, Adolescent, Nausea, Taiwan, Placebo, Young Adult, 03 medical and health sciences, Double-Blind Method, Internal medicine, medicine, Humans, Bipolar disorder, Adverse effect, Aged, Lurasidone, Glycemic, Psychiatric Status Rating Scales, Depressive Disorder, Major, business.industry, Malaysia, Lithuania, medicine.disease, 030227 psychiatry, Neurology (clinical), business, 030217 neurology & neurosurgery, Regular Articles |
| الوصف: | Aim Previous studies conducted primarily in the USA and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds, including those from Japan. Methods Patients were randomly assigned to double-blind treatment for 6 weeks with lurasidone, 20-60 mg/day (n = 184) or 80-120 mg/day (n = 169), or placebo (n = 172). The primary end-point was change from baseline to Week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS). Results Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the 20-60-mg/day group (-13.6; adjusted P = 0.007; effect size = 0.33), but not for the 80-120-mg/day group (-12.6; adjusted P = 0.057; effect size = 0.22) compared with placebo (-10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in weight, lipids, and measures of glycemic control. Conclusion Monotherapy with once daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning in patients with bipolar I depression. Results overall were consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations, including Japanese. |
| وصف الملف: | application/pdf |
| اللغة: | Spanish; Castilian |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0473aa61612b3c7c09217cf9bf92c8a6Test http://hdl.handle.net/2445/174801Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....0473aa61612b3c7c09217cf9bf92c8a6 |
| قاعدة البيانات: | OpenAIRE |
| الوصف غير متاح. |