Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial.

Autor: Suppes T; Stanford University School of Medicine, Stanford, California, USA.; US Department of Veterans Affairs Palo Alto Healthcare System, Palo Alto, California, USA., Durgam S; Intra-Cellular Therapies, Inc, New York City, New York, USA., Kozauer SG; Intra-Cellular Therapies, Inc, New York City, New York, USA., Chen R; Intra-Cellular Therapies, Inc, New York City, New York, USA., Lakkis HD; Intra-Cellular Therapies, Inc, New York City, New York, USA., Davis RE; Intra-Cellular Therapies, Inc, New York City, New York, USA., Satlin A; Intra-Cellular Therapies, Inc, New York City, New York, USA., Vanover KE; Intra-Cellular Therapies, Inc, New York City, New York, USA., Mates S; Intra-Cellular Therapies, Inc, New York City, New York, USA., McIntyre RS; Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, Ontario, Canada.; Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada.; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.; Department of Pharmacology, University of Toronto, Toronto, Ontario, Canada., Tohen M; Department of Psychiatry & Behavioral Sciences, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, USA.
Jazyk: angličtina
Zdroj: Bipolar disorders [Bipolar Disord] 2023 Sep; Vol. 25 (6), pp. 478-488. Date of Electronic Publication: 2023 Feb 26.
DOI: 10.1111/bdi.13310
Abstrakt: Objective: This phase 3, randomized, double-blind, placebo-controlled study (NCT02600507) evaluated the efficacy and safety of lumateperone adjunctive therapy to lithium or valproate in patients with bipolar depression.
Methods: Patients (18-75 years) with bipolar I or bipolar II disorder experiencing a major depressive episode (MDE), with inadequate therapeutic response to lithium or valproate, were randomized 1:1:1 to 6 weeks adjunctive therapy with lumateperone 28 mg (n = 176), lumateperone 42 mg (n = 177), or placebo (n = 176). The primary and key secondary efficacy endpoints were change from baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total score and the Clinical Global Impression Scale-Bipolar Version-Severity Scale (CGI-BP-S) depression subscore. Safety assessments included adverse events, laboratory evaluations, vital signs, extrapyramidal symptoms (EPS), and suicidality.
Results: Patients treated with adjunctive lumateperone 42 mg showed significantly greater improvement compared with adjunctive placebo in MADRS Total score (LS mean difference vs placebo [LSMD], -2.4; p = 0.02) and CGI-BP-S depression subscore (LSMD, -0.3; p = 0.01), while adjunctive lumateperone 28 mg showed numerical improvement in MADRS Total score (LSMD, -1.7; p = 0.10) and improvement in the CGI-BP-S depression subscore (LSMD, -0.3; p = 0.04). Adjunctive lumateperone treatment was well tolerated; treatment-emergent adverse events reported at rates >5% and twice placebo for lumateperone 42 mg were somnolence (11.3%), dizziness (10.7%), and nausea (8.5%), with minimal risk of EPS, metabolic abnormalities, or increased prolactin.
Conclusions: Lumateperone 42-mg treatment adjunctive to lithium or valproate significantly improved depression symptoms and was generally well tolerated in patients with MDEs associated with either bipolar I or bipolar II disorder.
(© 2023 Intra-Cellular Therapies, Inc and The Authors. Bipolar Disorders published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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