CNS spectrums · 2025
Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Durgam Suresh, Lakkis Hassan, Kozauer Susan G, Chen Changzheng, McIntyre Roger S
Аннотация
OBJECTIVE: Treatment options are limited for depressive episodes in patients with bipolar II disorder. This post hoc analysis evaluated the efficacy of lumateperone in three pooled short-term, Phase 3 studies in patients with a major depressive episode (MDE) associated with bipolar II disorder.
METHODS: This post hoc analysis pooled data from patients (18-75 years) with DSM-5 diagnosed bipolar II disorder experiencing an MDE in randomized, double-blind, placebo-controlled studies of lumateperone 42 mg monotherapy (Study 401, Study 404) and adjunctive therapy to lithium or valproate (Study 402). Primary and key secondary outcomes were change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total and Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) scores. Safety was also assessed.
RESULTS: Lumateperone significantly improved MADRS Total score at Day 43 in the bipolar II population (placebo, n = 87; lumateperone, n = 87; least squares mean difference vs. placebo [LSMD], -4.0; P < .05). In the bipolar II population, lumateperone significantly improved CGI-BP-S Total (LSMD, -1.0; P < .05), Depression (LSMD, -0.5; P < .05), and Overall Bipolar Illness scores (LSMD, -0.5; P < .05) compared with placebo at Day 43. No new safety signals were identified, with minimal risk of extrapyramidal symptoms, cardiometabolic abnormalities, or prolactin elevation.
CONCLUSIONS: Lumateperone 42 mg monotherapy or adjunctive therapy significantly improved symptoms of depression and disease severity in patients with bipolar II disorder across Phase 3 studies. Lumateperone was generally well tolerated. These results support lumateperone 42 mg to treat MDEs associated with bipolar II disorder.
METHODS: This post hoc analysis pooled data from patients (18-75 years) with DSM-5 diagnosed bipolar II disorder experiencing an MDE in randomized, double-blind, placebo-controlled studies of lumateperone 42 mg monotherapy (Study 401, Study 404) and adjunctive therapy to lithium or valproate (Study 402). Primary and key secondary outcomes were change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total and Clinical Global Impression Scale-Bipolar Version-Severity (CGI-BP-S) scores. Safety was also assessed.
RESULTS: Lumateperone significantly improved MADRS Total score at Day 43 in the bipolar II population (placebo, n = 87; lumateperone, n = 87; least squares mean difference vs. placebo [LSMD], -4.0; P < .05). In the bipolar II population, lumateperone significantly improved CGI-BP-S Total (LSMD, -1.0; P < .05), Depression (LSMD, -0.5; P < .05), and Overall Bipolar Illness scores (LSMD, -0.5; P < .05) compared with placebo at Day 43. No new safety signals were identified, with minimal risk of extrapyramidal symptoms, cardiometabolic abnormalities, or prolactin elevation.
CONCLUSIONS: Lumateperone 42 mg monotherapy or adjunctive therapy significantly improved symptoms of depression and disease severity in patients with bipolar II disorder across Phase 3 studies. Lumateperone was generally well tolerated. These results support lumateperone 42 mg to treat MDEs associated with bipolar II disorder.