CAPLYTA® (lumateperone)
CAPLYTA - Pivotal clinical trial publications
Adjunctive Major Depressive Disorder
Durgam S, et al. Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial. J Clin Psychiatry. 2025 Aug 25;86(4):25m15848.
Durgam S, Earley WR, Kozauer SG, Mo Y, Lakkis H, Edwards JB, Kornstein SG, Fava M. Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial. Am J Psychiatry. 2025 Dec 1;182(12):1072-1082.
Bipolar Disorder
Calabrese JR, et al. Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial. Am J Psychiatry. 2021 Dec;178(12):1098-1106.
Suppes T, Durgam S, Kozauer SG, Chen R, Lakkis HD, Davis RE, Satlin A, Vanover KE, Mates S, McIntyre RS, Tohen M. Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023 Sep;25(6):478-488.
Schizophrenia
Lieberman, JA, et al. ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial. Biological Psychiatry, Volume 79, Issue 12, 952 – 961
Correll CU, et al. Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):349-358. doi: 10.1001/jamapsychiatry.2019.4379. Erratum in: JAMA Psychiatry. 2020 Apr 1;77(4):438.
