Khan Nasar, Nasar Amina, Bajwa Saqib, Jawad Butt Aisha, Azher Afia, Mushtaq Tehmina, Rashid Alina, Haq Mian Mukhtar Ul, Rasul Ghulam, Dogar Firasat Ali
Division of Developmental Disabilities, Queens University, Kingston, ON, Canada.
Department of Psychiatry, Queens University, Kingston, ON, Canada.
Saudi J Biol Sci. 2021 Jan;28(1):1128-1132. doi: 10.1016/j.sjbs.2020.11.044. Epub 2020 Nov 24.
This study examined usefulness and efficiency of Lurasidone in appraisal with the placebo as for the treatment of Bipolar Disorders.
Seven treatment centers in Pakistan were selected for the purpose of starting a six week-long control trial (randomized and double-blind placebo). 76 subjects, already diagnosed with Bipolar I or II based on DSM 5 diagnosis, were selected after randomization. Patients were allocated in one of the two groups. Primary efficacy of the drug was measured using Young Mania Rating Scale. Positive response of the drug was defined as 50% reduction in symptoms from the baseline/13 point less than the baseline score on Young Mania Rating Scale. Efficacy and safety of the drug was assessed using variety of markers such as administering extra-pyramidal symptoms rating scale, adverse side effects reported, electrocardiograms, body weight, vital signs changes, and laboratory investigations.
Patients treated with Lurasidone showed enhanced improvement in their overall health and symptoms manifestation in comparison to patients who were given placebo Lurasidone treated patients showed a better response to the drug (66%), in comparison with the placebo treated patients (42%).
Study was conducted on small scale due to complexity.
Patients treated with Lurasidone showed reduction in bipolar symptoms and tolerate the drug well.
本研究以安慰剂为对照，考察了鲁拉西酮治疗双相情感障碍的有效性和安全性。
选取巴基斯坦的7个治疗中心开展一项为期6周的对照试验（随机双盲安慰剂对照）。根据DSM-5诊断标准，随机选取76例已确诊为双相I型或II型障碍的受试者。患者被分配到两组中的一组。使用杨氏躁狂评定量表测量药物的主要疗效。药物的阳性反应定义为症状较基线水平减轻50%/杨氏躁狂评定量表得分比基线得分低13分。使用多种指标评估药物的有效性和安全性，如使用锥体外系症状评定量表、报告的不良反应、心电图、体重、生命体征变化以及实验室检查。
与给予安慰剂的患者相比，接受鲁拉西酮治疗的患者整体健康状况和症状表现有更大改善。鲁拉西酮治疗的患者对药物的反应更好（66%），而安慰剂治疗的患者为（42%）。
由于情况复杂，研究规模较小。
接受鲁拉西酮治疗的患者双相症状减轻，且对药物耐受性良好。
