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CAPLYTA® (lumateperone)

Medical Information

CAPLYTA - Dosing - Higher Dose

Last Updated: 03/18/2026

SUMMARY

Based on clinical trials, the highest recommended daily dosage of CAPLYTA is 42 mg.¹
Johnson and Johnson does not recommend the use of CAPLYTA in a manner that is inconsistent with the prescribing information.
Lieberman et al (2016)² conducted a 4-week, phase 2, randomized, double-blind, placebo-controlled, active-controlled study to evaluate the efficacy and safety of lumateperone in patients with schizophrenia.
- Patients treated with lumateperone 84 mg (n=80) did not significantly separate from placebo on the PANSS total score. The least squares mean (LSM) (±Standard error of mean [SEM]) change was -8.3±1.68 from baseline to day 28 on the PANSS total score compared to placebo (n=80) (LSM [±SEM] change: -7.4±1.68; P=0.708)
- The most common treatment-emergent adverse events (TEAEs) occurring in more than 5% of patients receiving lumateperone 84 mg and considered at least possibly related to the study drug were sedation/somnolence, dry mouth, and dizziness.

PRODUCT LABELING

Recommended Dosage

The recommended CAPLYTA dosage is 42 mg administered orally once daily with or

without food. Dose titration is not needed.¹

CLINICAL DATA

Phase 2 Study

Lieberman et al (2016)² conducted a phase 2, randomized, double-blind, placebo-controlled, active-controlled study to evaluate the efficacy and safety of lumateperone in patients with schizophrenia. The primary endpoint was the change in the PANSS total score from baseline to day 28. Patients were randomly assigned (1:1:1:1) to receive either CAPLYTA 42 mg (n=84), lumateperone 84 mg (n=83), risperidone 4 mg (n= 82), or placebo (n=85) once daily in the morning for 4 weeks.

Results

There was a significant improvement in PANSS total score compared to placebo in the patients treated with CAPLYTA 42 mg. Patients treated with lumateperone 84 mg did not significantly separate from placebo on the PANSS total score. See Table: Change in PANSS Total score in the Modified Intent-to-Treat Population

Change in PANSS Total Score in the Modified Intent-to-Treat^a Population²

	CAPLYTA 42 mg	Lumateperone 84 mg	Risperidone 4 mg	Placebo
Total PANSS (MMRM) - Primary	n=76	n=80	n=75	n=80
LS mean (±SEM) change from baseline on day 28	−13.2±1.69	−8.3±1.68	−13.4±1.72	−7.4±1.68
LSMD rounded (vs placebo)	−5.8	−0.9	−6	n/a
Effect size	0.42	0.07	0.44	n/a
P-value	0.017	0.708	0.013	n/a
Abbreviations: LS, least square; LSMD, least square mean difference; MMRM, mixed-effects model repeated measures; n/a, not applicable; PANSS, Positive and Negative Syndrome Scale; SEM, standard error of the mean. ^aModified intent-to-treat population is defined as having a valid baseline PANSS assessment and at least 1 valid postdose assessment.

In the safety population (n=334), the most common TEAEs occurring in more than 5% of patients receiving lumateperone 84 mg (n=83) and considered at least possibly related to the study drug were sedation/somnolence (32.5%), dry mouth (8.4%), and dizziness (8.4%).

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 13 October 2025.

References

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1	CAPLYTA (lumateperone) [Prescribing Information]. Bedminster, NJ: Intra-Cellular Therapies, Inc; https://www.intracellulartherapies.com/docs/caplyta_pi.pdf
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.