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SUMMARY
- The concomitant use of CAPLYTA and SPRAVATO nasal spray has not been studied.
- In the phase 3 clinical trials for CAPLYTA in major depressive disorder, patients were excluded if they were on antidepressants outside of the approved background antidepressant therapy (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and bupropion).1-3
- Although select SPRAVATO phase 3 clinical trials permitted the concomitant use of certain classes of augmentation therapies including antipsychotics, no analyses have been conducted to evaluate the efficacy or safety of SPRAVATO in combination with CAPLYTA.4-7
Literature Search
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 13 April 2026.
| 1 | Durgam S, Earley WR, Kozauer SG, et al. Long-term adjunctive lumateperone 42 mg treatment in major depressive disorder: results from a 6-month open-label extension study. Eur Neuropsychopharmacol. 2026;108:112786. |
| 2 | Protocol for: Clinical trial of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov. Accessed 2025-05-02. Available via: https://clinicaltrials.gov/study/NCT04985942?term=NCT04985942&rank=1 |
| 3 | Protocol for: Multicenter study of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov. Accessed 2025-05-09. Available via: https://clinicaltrials.gov/study/NCT05061706?term=NCT05061706&rank=1 |
| 4 | Fu DJ, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). J Clin Psychiatry. 2020;81(3):19m13191. |
| 5 | Ionescu DF, Fu DJ, Qiu X, et al. Esketamine nasal spray for rapid reduction of depressive symptoms in patients with major depressive disorder who have active suicide ideation with intent: results of a phase 3, double-blind, randomized study (ASPIRE II). Int J Neuropsychopharmacol. 2021;24(1):22-31. |
| 6 | Zaki N, Chen L, Lane R, et al. Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Int J Neuropsychopharmacol. 2025;28(6):pyaf027. |
| 7 | Zaki N, Chen L, Lane R, et al. Supplement to: Safety and efficacy with esketamine in treatment-resistant depression: long-term extension study. Int J Neuropsychopharmacol. 2025;28(6):pyaf027. |
