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SUMMARY
- There are no studies or reports regarding the use of CAPLYTA in patients with comorbid substance abuse disorders.
- Comorbid substance abuse disorder was an exclusion criterion in the CAPLYTA clinical trial programs.1-6
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) conducted on 18 September 2025 did not identify any relevant citations pertaining to this topic.
| 1 | Correll CU, Davis RE, Weingart M, et al. Supplement to: Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020;77(4):349-358. |
| 2 | Lieberman JA, Davis RE, Correll CU, et al. ITI-007 for the treatment of schizophrenia: a 4-week randomized, double-blind, controlled trial. Biol Psychiatry. 2016;79(12):952-961. |
| 3 | Calabrese JR, Durgam S, Satlin A, et al. Supplement to: 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;178(12):1098-1106. |
| 4 | Suppes T, Durgam S, Kozauer SG, et al. Supplement to: Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023;25(6):478-488. |
| 5 | Data on File. CAPLYTA. Clinical Study Report of Study 501. Intra-Cellular Therapies, Inc; 2024. |
| 6 | Data on File. CAPLYTA. Clinical Study Report of Study 502. Intra-Cellular Therapies, Inc; 2024. |
