Lumateperone Phase 3. This Phase 3 open-label extension trial, Study 503 (NCT0506

This Phase 3 open-label extension trial, Study 503 (NCT05061719), investigated the long-term safety of adjunctive lumateperone 42mg in patients who completed Study 501 or 502. This phase 3, randomized, double-blind, placebo-controlled trial investigated efficacy and safety of adjunctive lumateperone 42 mg in patients with major depressive disorder (MDD) with This Phase 3, randomized, double-blind, placebo-controlled, multicenter trial (Study 501; NCT04985942) investigated the efficacy and safety of adjunctive lumateperone 42 mg in patients with MDD with Lumateperone+ADT was generally safe and well tolerated in patients with MDD with inadequate ADT response and had statistically significant and clinically meaningful improvement in depression Abstract Objective This phase 3, randomized, double-blind, placebo-controlled study (NCT02600507) evaluated the efficacy and safety of (17), make lumateperone an attractive candidate for the treatment of mood disorders. This phase 3, randomized, double-blind, placebo-controlled trial investigated efficacy and safety of adjunctive lumateperone 42 mg in patients A phase 3 trial shows lumateperone added to antidepressant therapy delivers greater symptom improvement and maintains a favorable safety profile in adults with MDD. The efficacy and safety of CAPLYTA (lumateperone) as a maintenance treatment in adults with schizophrenia was demonstrated in a randomized withdrawal trial The study demonstrated a In a Phase 3, randomized, double-blind, placebo-controlled trial (Study 403; NCT04285515) lumateperone 42mg was efficacious over placebo with a favorable safety profile in patients with MDD Abstract Objective: A post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled outpatient study investigated efficacy of lumateperone 42 mg in patients with bipolar I or The efficacy and safety of lumateperone adjunctive to ADT was evaluated in 2 Phase 3, randomized, double-blind, placebo-controlled studies (501, NCT04985942; 502, NCT05061706) in Poster W85 “Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From an Additional Randomized, Double-Blind, Phase 3 Trial,” Wednesday, December 11 This similarly designed randomized, double-blind, placebo-controlled, multicenter, Phase 3 study provides additional safety information on A recent Phase 3, randomized, double-blind, placebo-controlled study established that lumateperone 42-mg monotherapy significantly improved symptoms of depression in patients with This study aimed to evaluate the efficacy and safety of lumateperone in treating bipolar disorder and schizophrenia. In a recent Phase 3, randomized, double-blind, placebo-controlled, multicenter trial (Study 501; NCT04985942), with lumateperone + ADT compared with placebo + ADT at Day 43 (Figure 3) Self . This This phase 3, randomized, double-blind, placebo-controlled trial evaluated lumateperone 42 mg (a simultaneous modulator of serotonin, “In this Phase 3 study, lumateperone demonstrated a robust effect as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant In a Phase 3, randomized, double-blind, placebo-controlled trial (Study 403; NCT04285515) lumateperone 42mg was efficacious over placebo with a favorable safety profile in patients with MDD New positive results demonstrate the efficacy and safety of lumateperone (Caplyta) 42 mg for the prevention of relapse in adult patients with New phase 3 data support the FDA approval of lumateperone, showing early efficacy and favorable tolerability as an adjunctive treatment for MDD. A comprehensive literature search was Both lumateperone doses were well tolerated without clinically significant treatment-emergent motor adverse effects or changes in cardiometabolic or endocrine factors vs placebo. In late-phase controlled clini-cal trials in schizophrenia, lumateperone treatment for up to 4 weeks was effective We would like to show you a description here but the site won’t allow us. In both studies, lumateperone 42 mg + ADT met the primary endpoint, with significant improvement in depressive symptoms vs placebo + ADT, and was generally well tolerated. Efficacy of Lumateperone 42 mg in the Treatment of Major Depressive Disorder: A Pooled Analysis of Phase 3 Randomized Controlled Trials Suresh Durgam, MD1; Willie R. Earley, MD1; Susan G. Background: Efficacy and Safety of Lumateperone • The efficacy and safety of lumateperone adjunctive to ADT was evaluated in 2 Phase 3 studies in patients who had inadequate response to 1-2 ADTs in This randomized clinical trial examines the efficacy and safety of lumateperone for the short-term treatment of adults with schizophrenia.

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