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SUMMARY
- Brain trauma was an exclusion criterion for many of the CAPLYTA studies.1-8
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) conducted on 29 June 2026 did not identify any relevant citations pertaining to this topic.
| 1 | 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. |
| 2 | 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. |
| 3 | Durgam S, Kozauer SG, Earley WR, et al. Supplement to: Lumateperone for the treatment of major depressive disorder with mixed features or bipolar depression with mixed features: a randomized placebo-controlled trial. J Clin Psychopharmacol. 2025;45(2):67-75. |
| 4 | Protocol for: A phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with bipolar I or II disorder (bipolar depression) conducted globally. ClinicalTrials.gov. Accessed 2026-07-10. https://cdn.clinicaltrials.gov/large-docs/76/NCT03249376/Prot_000.pdf |
| 5 | Durgam S, Earley WR, Kzauer SG, et al. Supplement to: Adjunctive lumateperone in patients with major depressive disorder: results from a randomized double-blind phase 3 trial. Am J Psychiatry. 2025;182(12):1072-1082. |
| 6 | Durgam S, Earley WR, Kozauer SG, et al. Supplement to: Lumateperone as adjunctive therapy in patients with major depressive disorder: results from a randomized, double-blind, phase 3 trial. J Clin Psychiatry. 2025;86(4):25m15848. |
| 7 | Protocol for: A phase 3, randomized, double-blind, placebo-controlled, multi-center study with an open-label extension to assess the efficacy and safety of ITI-007 monotherapy in the treatment of patients with major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression). ClinicalTrials.gov. 2026-07-16. https://cdn.clinicaltrials.gov/large-docs/94/NCT02600494/Prot_000.pdf |
| 8 | Protocol for: A phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ITI-007 adjunctive to lithium or valproate in the treatment of patients with major depressive episodes associated with bipolar I or II disorder (bipolar depression). ClinicalTrials.gov. 2026-07-16. https://cdn.clinicaltrials.gov/large-docs/07/NCT02600507/Prot_000.pdf |
