Safety and Efficacy of Levomilnacipran Extended Release in Pediatric Patients Aged 7-17 Years with Major Depressive Disorder: Results of Two Phase 3, Randomized, Double-Blind Studies.

IF 1.5 4区 医学 Q2 PEDIATRICS Journal of child and adolescent psychopharmacology Pub Date : 2024-06-01 Epub Date: 2024-05-03 DOI:10.1089/cap.2023.0080
Daniel T Radecki, Weining Z Robieson, Mallika Gopalkrishnan, Edward Greenberg, Mohamed Aziz
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Abstract

Objective: Major depressive disorder (MDD) presents a significant psychosocial burden, and there is an unmet need for additional treatment options in pediatric patients. Here, we report the results of two phase 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies evaluating the efficacy and safety of levomilnacipran extended release in children and adolescents with MDD. Methods: In the first study, LVM-MD-11, patients aged 12-17 years received daily doses of levomilnacipran 40 mg (n = 134), levomilnacipran 80 mg (n = 138), fluoxetine 20 mg (n = 134), or placebo (n = 141). In the second study, LVM-MD-14, patients aged 7-17 years received levomilnacipran 40 to 80 mg (n = 166), fluoxetine 20 mg (n = 166), or placebo (n = 160) daily. Primary and secondary efficacy endpoints were changes in Children's Depression Rating Scale-Revised (CDRS-R) total score and Clinical Global Impressions-Severity (CGI-S) score, respectively. Results: In LVM-MD-11, there were no significant differences in change in CDRS-R total score between patients treated daily with placebo (least squares mean [LSM] change in CDRS-R total score -22.9) versus levomilnacipran 40 mg (-23.3; p = 0.8035) or 80 mg (-22.6; p = 0.8681). Similarly, in LVM-MD-14, there were no significant differences in LSM change in CDRS-R total score with placebo (-21.3) versus levomilnacipran 40 to 80 mg daily (-23.0; p = 0.2215). There were also no significant differences between the fluoxetine and placebo groups in either study for changes in CDRS-R total score. Changes in CGI-S score were not significant between placebo and levomilnacipran 40 to 80 mg daily or between placebo and fluoxetine. Levomilnacipran was generally well tolerated. Conclusions: The high placebo response in this study prevented the detection of an effect of levomilnacipran in children and adolescents. Clinical Trial Registration numbers: NCT02431806 and NCT03569475.

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左米那西普仑缓释片对 7-17 岁重度抑郁症儿童患者的安全性和疗效:两项 3 期随机双盲研究的结果。
目的:重度抑郁障碍(MDD)是一种严重的社会心理负担,儿童患者对更多治疗方案的需求尚未得到满足。在此,我们报告了两项第三阶段多中心、随机、双盲、安慰剂和活性对照、平行组研究的结果,这些研究评估了左旋米那西普仑缓释片在儿童和青少年 MDD 患者中的疗效和安全性。研究方法在第一项研究LVM-MD-11中,12-17岁的患者每天分别服用左旋米那西普兰40毫克(134人)、左旋米那西普兰80毫克(138人)、氟西汀20毫克(134人)或安慰剂(141人)。在第二项研究LVM-MD-14中,7-17岁的患者每天接受40-80毫克左旋米那西普兰(166人)、20毫克氟西汀(166人)或安慰剂(160人)治疗。主要和次要疗效终点分别为儿童抑郁量表-修订版(CDRS-R)总分和临床总体印象-严重程度(CGI-S)评分的变化。结果在LVM-MD-11中,每天服用安慰剂(CDRS-R总分最小二乘法均值[LSM]变化为-22.9)与服用左旋米那西普仑40毫克(-23.3;P = 0.8035)或80毫克(-22.6;P = 0.8681)的患者之间,CDRS-R总分的变化没有显著差异。同样,在LVM-MD-14中,安慰剂(-21.3)与每日服用左旋米那西普仑40至80毫克(-23.0;p = 0.2215)相比,CDRS-R总分的LSM变化没有显著差异。在这两项研究中,氟西汀组和安慰剂组的 CDRS-R 总分变化也无明显差异。CGI-S评分的变化在安慰剂组和每日服用40至80毫克左旋米那西普兰组之间以及安慰剂组和氟西汀组之间均无显著差异。左旋米那西普兰的耐受性普遍良好。结论:本研究中安慰剂的高应答率阻碍了左旋米那西普兰对儿童和青少年的疗效检测。临床试验注册号:NCT02431806和NCT03569475。
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来源期刊
CiteScore
3.60
自引率
5.30%
发文量
61
审稿时长
>12 weeks
期刊介绍: Journal of Child and Adolescent Psychopharmacology (JCAP) is the premier peer-reviewed journal covering the clinical aspects of treating this patient population with psychotropic medications including side effects and interactions, standard doses, and research on new and existing medications. The Journal includes information on related areas of medical sciences such as advances in developmental pharmacokinetics, developmental neuroscience, metabolism, nutrition, molecular genetics, and more. Journal of Child and Adolescent Psychopharmacology coverage includes: New drugs and treatment strategies including the use of psycho-stimulants, selective serotonin reuptake inhibitors, mood stabilizers, and atypical antipsychotics New developments in the diagnosis and treatment of ADHD, anxiety disorders, schizophrenia, autism spectrum disorders, bipolar disorder, eating disorders, along with other disorders Reports of common and rare Treatment Emergent Adverse Events (TEAEs) including: hyperprolactinemia, galactorrhea, weight gain/loss, metabolic syndrome, dyslipidemia, switching phenomena, sudden death, and the potential increase of suicide. Outcomes research.
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