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CAPLYTA®

(lumateperone)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

CAPLYTA® (lumateperone)

Medical Information

CAPLYTA - Use in Pediatric and Young Adult Patients

Last Updated: 11/12/2025

SUMMARY  

  • SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor all antidepressant-treated patients for worsening and emergence of suicidal thoughts and behaviors.1  
  • Safety and effectiveness of CAPLYTA have not been established in pediatric patients.1
  • CAPLYTA is not approved for use in pediatric or young adult patients (<18 years).
  • No prospective, randomized trials have been conducted to evaluate the safety and efficacy of CAPLYTA in pediatric or young adult patients.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) conducted on 12 September 2025 did not identify any relevant citations pertaining to this topic.

 

References

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