From the Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA.
J Clin Psychopharmacol. 2018 Jun;38(3):207-211. doi: 10.1097/JCP.0000000000000867.
To retrospectively assess lurasidone effectiveness/efficacy/tolerability in bipolar disorder (BD) patients.
Outpatients assessed with Systematic Treatment Enhancement Program for BD Affective Disorders Evaluation received naturalistically administered (primarily adjunctive) open lurasidone while monitored at visits with the Systematic Treatment Enhancement Program for BD Clinical Monitoring Form.
Sixty-one patients (32 type I, 26 type II, 3 type not otherwise specified; mean ± SD age, 45.1 ± 14.0 years; 63.9% were female) received lurasidone with 3.1 ± 1.4 (≥2 in 88.5%, monotherapy in only 3.3%) other nonanxiolytic/hypnotic prescription psychotropics, started during syndromal depression in 57.4%, subsyndromal depression in 23.0%, and euthymia in 19.7%. Lurasidone was taken for median 126 days, with final dose 55.6 ± 30.8 mg/d. By final visit taking lurasidone, syndromal depression rate decreased by nearly one-half to 31.1%, and euthymia rate more than doubled to 42.6%, whereas subsyndromal depression rate was unchanged at 23.0%. Clinical Global Impressions-BD-Overall Severity improved significantly only in patients with baseline syndromal depression. Seventy-seven percent of patients discontinued lurasidone after median 103 days, because of adverse events in 54.1% (most often akathisia, sedation/somnolence, nausea, and weight gain), inefficacy in 16.4%, and other reasons in 6.6%; 12.1% had equal to or greater than 7% weight gain, and 3.3% developed hypomania. Limitations to this study were the open design and demographically homogeneous (relatively affluent, predominantly white female) small sample taking complex pharmacotherapy.
In American specialty clinic BD outpatients, adjunctive longer-term lurasidone commonly relieved syndromal depression and maintained euthymia, suggesting possible effectiveness/efficacy. However, lurasidone was discontinued in 54.1% because of adverse events, suggesting tolerability limitations in these challenging patients, nearly 90% of whom were already taking at least 2 other nonanxiolytic/hypnotic prescription psychotropics.
回顾性评估鲁拉西酮在双相障碍（BD）患者中的疗效/疗效/耐受性。
接受系统治疗增强计划 BD 情感障碍评估的门诊患者接受了自然给予的（主要是辅助性的）开放鲁拉西酮治疗，同时在系统治疗增强计划 BD 临床监测表的就诊时进行监测。
61 名患者（32 名 I 型，26 名 II 型，3 名非特定类型；平均年龄±标准差，45.1±14.0 岁；63.9%为女性）接受了鲁拉西酮治疗，同时还服用了 3.1±1.4（≥2 的占 88.5%，仅用单药治疗的占 3.3%）种其他非抗焦虑/催眠的处方精神药物，起始治疗处于综合征性抑郁期的占 57.4%，亚综合征性抑郁期的占 23.0%，轻躁狂期的占 19.7%。鲁拉西酮的中位服用时间为 126 天，最终剂量为 55.6±30.8mg/d。在最后一次服用鲁拉西酮时，综合征性抑郁的发生率下降了近一半，降至 31.1%，轻躁狂的发生率增加了一倍以上，达到 42.6%，而亚综合征性抑郁的发生率则保持不变，为 23.0%。仅基线时患有综合征性抑郁的患者的临床总体印象-BD-总体严重程度显著改善。77%的患者在中位 103 天后停止服用鲁拉西酮，原因是不良反应（54.1%）、无效（16.4%）和其他原因（6.6%）。12.1%的患者体重增加了等于或大于 7%，3.3%的患者出现了轻躁狂。这项研究的局限性在于开放性设计和人口统计学上的同质性（相对富裕、以白人女性为主），以及样本量小，服用了复杂的药物治疗。
在接受美国专科诊所 BD 门诊治疗的患者中，辅助性长期服用鲁拉西酮通常可缓解综合征性抑郁并维持轻躁狂，表明其可能具有有效性/疗效。然而，由于不良反应，54.1%的患者停止了服用鲁拉西酮，这表明在这些具有挑战性的患者中，耐受性可能存在限制，这些患者中近 90%的患者已经服用了至少 2 种其他非抗焦虑/催眠的处方精神药物。
