Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder.

IF 4.2 2区医学 Q1 PSYCHIATRY

Journal of Clinical Psychiatry Pub Date : 2026-09-02 DOI:10.4088/JCP.26m16387

Anita H Clayton, Willie R Earley, Susan G Kozauer, Yifan Mo, John B Edwards, Suresh Durgam

{"title":"Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder.","authors":"Anita H Clayton, Willie R Earley, Susan G Kozauer, Yifan Mo, John B Edwards, Suresh Durgam","doi":"10.4088/JCP.26m16387","DOIUrl":null,"url":null,"abstract":"Objective: Lumateperone is an atypical antipsychotic to treat schizophrenia, bipolar I or II depression, and major depressive disorder (MDD). Randomized phase 3 Study 502 (NCT05061706) investigated the impact of adjunctive lumateperone 42 mg/day on sexual functioning, per Changes in Sexual Functioning Questionnaire 14-item version (CSFQ-14).Methods: Adults meeting DSM-5 criteria for MDD with inadequate response to 1-2 antidepressant therapies (ADTs) in the current depressive episode, Montgomery-Åsberg Depression Rating Scale Total score ≥24, Clinical Global Impression Scale-Severity score ≥4, and Quick Inventory of Depressive Symptomatology-Self Report-16-item score ≥14 were randomized to 6-week lumateperone 42 mg+ADT or placebo+ADT. Sexual function was assessed by CSFQ-14 Total and domain scores in the intent-to-treat (ITT) population and subgroups.Results: Of 480 patients in the ITT population, 82.5% had sexual dysfunction at baseline (women=284; men=112). Lumateperone+ADT significantly improved CSFQ-14 Total score at Day 43 vs placebo+ADT (least squares mean difference [LSMD]=2.7; effect size [ES]=0.38; P<.0001). Significantly greater improvements were observed in patients with baseline sexual dysfunction (LSMD=3.1; ES=0.42; P<.0001), with no change in those without. Improvements were observed in women (LSMD=3.5; ES=0.47; P<.0001) and in men (LSMD=1.9; ES=0.33; P=.08). Significant improvements in CSFQ-14 Total score at Day 43 were observed across age groups and CSFQ domain scores, with both sexes having significant improvements in pleasure and desire/interest. Improvements in depressive symptoms may be linked to improvement in sexual functioning.Conclusions: Adjunctive lumateperone 42 mg did not worsen sexual functioning and was not associated with treatment-related sexual dysfunction in patients with MDD with inadequate response to ADT.Trial Registration: ClinicalTrials.gov identifier: NCT05061706.","PeriodicalId":50234,"journal":{"name":"Journal of Clinical Psychiatry","volume":"87 3","pages":""},"PeriodicalIF":4.2000,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Psychiatry","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4088/JCP.26m16387","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}

引用次数: 0

Abstract

Objective: Lumateperone is an atypical antipsychotic to treat schizophrenia, bipolar I or II depression, and major depressive disorder (MDD). Randomized phase 3 Study 502 (NCT05061706) investigated the impact of adjunctive lumateperone 42 mg/day on sexual functioning, per Changes in Sexual Functioning Questionnaire 14-item version (CSFQ-14).

Methods: Adults meeting DSM-5 criteria for MDD with inadequate response to 1-2 antidepressant therapies (ADTs) in the current depressive episode, Montgomery-Åsberg Depression Rating Scale Total score ≥24, Clinical Global Impression Scale-Severity score ≥4, and Quick Inventory of Depressive Symptomatology-Self Report-16-item score ≥14 were randomized to 6-week lumateperone 42 mg+ADT or placebo+ADT. Sexual function was assessed by CSFQ-14 Total and domain scores in the intent-to-treat (ITT) population and subgroups.

Results: Of 480 patients in the ITT population, 82.5% had sexual dysfunction at baseline (women=284; men=112). Lumateperone+ADT significantly improved CSFQ-14 Total score at Day 43 vs placebo+ADT (least squares mean difference [LSMD]=2.7; effect size [ES]=0.38; P<.0001). Significantly greater improvements were observed in patients with baseline sexual dysfunction (LSMD=3.1; ES=0.42; P<.0001), with no change in those without. Improvements were observed in women (LSMD=3.5; ES=0.47; P<.0001) and in men (LSMD=1.9; ES=0.33; P=.08). Significant improvements in CSFQ-14 Total score at Day 43 were observed across age groups and CSFQ domain scores, with both sexes having significant improvements in pleasure and desire/interest. Improvements in depressive symptoms may be linked to improvement in sexual functioning.

Conclusions: Adjunctive lumateperone 42 mg did not worsen sexual functioning and was not associated with treatment-related sexual dysfunction in patients with MDD with inadequate response to ADT.

Trial Registration: ClinicalTrials.gov identifier: NCT05061706.

查看原文本刊更多论文

辅助治疗Lumateperone对重度抑郁症患者性功能的评价。

目的：Lumateperone是一种治疗精神分裂症、双相I或II型抑郁症和重度抑郁症（MDD）的非典型抗精神病药物。随机3期研究502 （NCT05061706）根据性功能变化问卷14项版本（CSFQ-14）调查了辅助服用42毫克/天的lumateperone对性功能的影响。方法：符合DSM-5标准且当前抑郁发作中对1-2种抗抑郁药物（ADTs）反应不足的MDD成人，Montgomery-Åsberg抑郁评定量表总分≥24分，临床总体印象量表-严重性评分≥4分，抑郁症状快速量表-自我报告-16项评分≥14分随机分为6周的lumateperone 42 mg+ADT或安慰剂+ADT。在意向治疗（ITT）人群和亚组中，用CSFQ-14总分和域评分评估性功能。结果：ITT人群中的480例患者中，82.5%在基线时存在性功能障碍（女性=284；男性=112）。与安慰剂+ADT相比，Lumateperone+ADT显著改善第43天CSFQ-14总分（最小二乘平均差[LSMD]=2.7；效应量[ES]=0.38； PPPP= 0.08）。第43天，各年龄组的CSFQ-14总分和CSFQ域得分均有显著改善，两性在愉悦感和兴奋感方面均有显著改善。抑郁症状的改善可能与性功能的改善有关。结论：对于ADT反应不充分的MDD患者，辅助使用lumaterperone 42 mg不会使性功能恶化，也与治疗相关性性功能障碍无关。试验注册：ClinicalTrials.gov标识符：NCT05061706。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of Clinical Psychiatry 医学-精神病学

CiteScore

7.40

自引率

1.90%

发文量

审稿时长

3-8 weeks

期刊介绍： For over 75 years, The Journal of Clinical Psychiatry has been a leading source of peer-reviewed articles offering the latest information on mental health topics to psychiatrists and other medical professionals.The Journal of Clinical Psychiatry is the leading psychiatric resource for clinical information and covers disorders including depression, bipolar disorder, schizophrenia, anxiety, addiction, posttraumatic stress disorder, and attention-deficit/hyperactivity disorder while exploring the newest advances in diagnosis and treatment.