J&J Medical Connect
CAPLYTA®

(lumateperone)

+ Save link
J&J Medical Connect

Connect with us

Connect with us

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 - Adverse Events - Dyskinesia

Last Updated: 11/10/2025

SUMMARY

  • If signs and symptoms of tardive dyskinesia appear in CAPLYTA-treated patients, consider drug discontinuation.1

Schizophrenia

  • In 3 placebo-controlled, 4- to 6-week trials, dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg (n=406), 1 patient (0.2%) receiving placebo (n=412), and 0 patients receiving risperidone (n=255) (narrow standardized Medical Dictionary for Regulatory Activities query [SMQ]). Tardive dyskinesia was reported in 2 patients (0.5%) receiving CAPLYTA 42 mg, 0 patients receiving placebo, and 0 patients receiving risperidone (narrow SMQ).2 
  • In a long-term, open-label, 1-year study, dyskinesia and tardive dyskinesia were reported in 1 patient each (0.2%; N=602) receiving CAPLYTA 42 mg (narrow SMQ).3 

Bipolar Depression

  • In a 6-week, phase 3, randomized, double-blind, placebo-controlled study, 1 patient (0.5%; n=188) in the CAPLYTA 42 mg group experienced mild dyskinesia.4 
  • In a pooled analysis of two 6-week, placebo-controlled trials of CAPLYTA 42 mg monotherapy and a placebo-controlled trial of CAPLYTA 42 mg adjunctive to lithium or valproate, dyskinesia was reported in 1 patient (0.3%) receiving CAPLYTA 42 mg monotherapy (n=372).5 

Major Depressive Disorder

  • In a 6-week, placebo-controlled trial of CAPLYTA 42 mg adjunctive to antidepressant therapy (ADT), dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg+ADT (n=241) and in 1 patient (0.4%) receiving placebo+ADT (n=243) (narrow SMQ).6 
  • In a 26-week, open-label trial of CAPLYTA 42 mg adjunctive to ADT, dyskinesia was reported in 2 patients (0.2%; N=809) (narrow SMQ).7 

PRODUCT LABELING

Tardive dyskinesia may develop in patients treated with antipsychotic drugs, including CAPLYTA. Tardive dyskinesia can develop after a relatively brief treatment period at low dosages and may also occur after discontinuation of treatment. If antipsychotic treatment is discontinued, tardive dyskinesia may partially or completely remit. Antipsychotic treatment, however, may suppress or partially suppress the signs and symptoms of tardive dyskinesia, and may mask the underlying process. The effect that symptomatic suppression has upon the long-term course of tardive dyskinesia is unknown.1

The tardive dyskinesia risk appears to be highest among the elderly, especially elderly women, but it is not possible to predict which patients are likely to develop tardive dyskinesia. The tardive dyskinesia risk and the likelihood that tardive dyskinesia will become irreversible increase with the duration of antipsychotic drug treatment and the cumulative dosage.1

Periodically reassess the need for continued treatment. If signs and symptoms of tardive dyskinesia appear in CAPLYTA-treated patients, consider drug discontinuation. However, some patients may require CAPLYTA treatment despite the presence of tardive dyskinesia.1

CLINICAL DATA


Summary of Clinical Studies
Study
Treatment Groups
Outcomes
Schizophrenia
Three placebo-controlled, 4- to 6-week trials of adult patients with schizophrenia.2
  • CAPLYTA 42 mg (n=406)
  • Placebo (n=412)
  • Risperidone (n=255)
  • Dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg, 1 patient (0.2%) receiving placebo, and 0 patients receiving risperidone (narrow SMQ).
  • Tardive dyskinesia was reported in 2 patients (0.5%) receiving CAPLYTA 42 mg, 0 patients receiving placebo, and 0 patients receiving risperidone (narrow SMQ).
Long-term, open-label study of patients with schizophrenia who received CAPLYTA 42 mg for up to 1 year.3 
  • CAPLYTA 42 mg (N=602)
  • Dyskinesia and tardive dyskinesia were reported in 1 patient each (0.2%) (narrow SMQ).
Bipolar Depression
Calabrese et al (2021)4 conducted a 6-week, phase 3, randomized, double-blind, placebo-controlled study in patients with bipolar I or bipolar II disorder experiencing an MDE. 
  • CAPLYTA 42 mg (n=188)
  • Placebo (n=189)
  • Mild dyskinesia was reported in 1 patient (0.5%) in the CAPLYTA 42 mg group on day 43 and was considered drug-related.
Escher et al (2022)5 conducted a pooled clinical analysis of patients with bipolar I or bipolar II disorder who were experiencing an MDE that included data from two 6-week, placebo-controlled trials of CAPLYTA 42 mg monotherapy (studies 401 and 404) and a placebo-controlled trial of CAPLYTA 42 mg adjunctive to lithium or valproate (study 402). 
  • CAPLYTA 42 mg monotherapy (n=372)
  • CAPLYTA 42 mg adjunctive to lithium or valproate (n=177)
  • Placebo monotherapy (n=374)
  • Placebo adjunctive to lithium or valproate (n=175)
  • One patient (0.3%) on CAPLYTA 42 mg monotherapy experienced mild dyskinesia.
Major Depressive Disorder
In a 6-week, placebo-controlled trial, adult patients with MDD were randomized (1:1) to receive CAPLYTA 42 mg adjunctive to ADT or placebo adjunctive to ADT.6
  • CAPLYTA 42 mg+ADT (n=241)
  • Placebo+ADT (n=243)
  • Dyskinesia was reported in 0 patients receiving CAPLYTA 42 mg+ADT and in 1 patient (0.4%) receiving placebo+ADT (narrow SMQ).
In a 26-week, open-label trial, adult patients with MDD received CAPLYTA 42 mg adjunctive to ADT.7
  • CAPLYTA 42 mg+ADT (N=809)
  • Dyskinesia was reported in 2 patients (0.2%) (narrow SMQ).
Abbreviations: ADT, antidepressant therapy; MDD, major depressive disorder; MDE, major depressive episode; SMQ, standard Medical Dictionary for Regulatory Activities query.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 23 September 2025.

References

Show
1 CAPLYTA (lumateperone) [Prescribing Information]. Bedminster, NJ: Intra-Cellular Therapies, Inc; https://www.intracellulartherapies.com/docs/caplyta_pi.pdf
2 Data on File. CAPLYTA. Integrated Summary of Safety. Intra-Cellular Therapies, Inc; 2025.  
3 Data on File. CAPLYTA. Clinical Study Report of Study 303. Intra-Cellular Therapies, Inc; 2025.  
4 Calabrese JR, Durgam S, Satlin A, et al. 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.  
5 Escher T, Durgam S, Kozauer SG, et al. Lumateperone in the treatment of major depressive episodes associated with bipolar I or bipolar II disorder: evaluation of extrapyramidal and motor symptoms in late-phase clinical trials [abstract]. Neuropsychopharmacology. 2022;47(Suppl. 1):202-203. Abstract P243.  
6 Data on File. CAPLYTA. Clinical Study Report of Study 501. Intra-Cellular Therapies, Inc; 2024.  
7 Data on File. CAPLYTA. Clinical Study Report of Study 503. Intra-Cellular Therapies, Inc; 2025.