J&J Medical Connect
CAPLYTA®

(lumateperone)

J&J Medical Connect

Connect with us

  • Products

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 - Dosing - Conversion to/from Another Antipsychotic

Last Updated: 03/17/2026

SUMMARY

  • There are no systematically collected data to specifically address switching patients from other antipsychotics to CAPLYTA or from CAPLYTA to other antipsychotics.
  • Conversion to or from CAPLYTA should be based on clinical judgment and individual patient factors. For information pertaining to discontinuation of specific antipsychotics, please refer to the respective manufacturer’s prescribing information.
  • In studies evaluating CAPLYTA for schizophrenia, antipsychotic medications were discontinued for a specified period of time prior to study medication.1-7 
  • In studies evaluating CAPLYTA for bipolar depression or MDD, patients exposed to antipsychotics within a period of time before baseline visit or after screening were generally excluded.8-22

CLINICAL DATA


Summary of Clinical Studies of CAPLYTA
Study Objective
Patients and Treatment Groups
Switching/Conversion
Schizophrenia
A randomized, double-blind, placebo-controlled, phase 2 study (study 005) evaluated the efficacy and safety of CAPLYTA in patients with an acute exacerbation of schizophrenia.1,2 
  • Patients (N=335) were randomized to receive CAPLYTA 42 mg, CAPLYTA 84 mg, risperidone (active control), or placebo for 4 weeks.
  • Patients were required to discontinue use of any depot antipsychotic within 1 treatment cycle prior to study medication, discontinue use of any antipsychotic medication 1 week prior to receiving study medication, and discontinue use of mianserin, mirtazapine, nefazodone, cyproheptadine, or fluvoxamine within 30 days prior to study medication.
Two randomized, double‑blind, placebo‑controlled, phase 3 studies (studies 301 and 302) evaluated the efficacy and safety of CAPLYTA in patients with an acute exacerbation of schizophrenia.3-5 
  • Study 301: patients (N=450) were randomized to receive CAPLYTA 42 mg, lumateperone 28 mg, or placebo for 4 weeks.
  • Study 302: patients (N=696) were randomized to receive CAPLYTA 42 mg, CAPLYTA 14 mg, risperidone (active control), or placebo for 6 weeks.
  • Patients were required to discontinue use of any antipsychotic medication 1 week prior to receiving study medication, discontinue use of any depot antipsychotic within 1.5 treatment cycles prior to study medication, and discontinue use of mianserin, mirtazapine, nefazodone, cyproheptadine, pimavanserin, or fluvoxamine within 30 days (study 301) or 5 half-lives (study 302) prior to study medication.
A 2-part, open-label, long‑term, phase 3 study (study 303) evaluated the efficacy and safety of CAPLYTA in patients with schizophrenia.6,7
  • Patients (N=602) received CAPLYTA 42 mg for up to 1 year.
  • Patients were required to discontinue use of any antipsychotic medication prior to receiving study medication.
Bipolar Depression
Four randomized, double‑blind, placebo-controlled, phase 3 studies (study 401, 402, 403, and 404) evaluated the efficacy and safety of CAPLYTA in patients with MDEs associated with bipolar depression.8-16
  • Study 401: patients (N=554) were randomized to receive CAPLYTA 42 mg, lumateperone 28 mg, or placebo for 6 weeks.
  • Study 402: patients (N=529) were randomized to receive CAPLYTA 42 mg, lumateperone 28 mg, or placebo adjunctive to lithium or valproate for 6 weeks.
  • Study 403: patients (N=388) were randomized to receive CAPLYTA 42 mg or placebo for 6 weeks.
  • Study 404: patients (N=381) were randomized to receive CAPLYTA 42 mg or placebo for 6 weeks.
  • Patients who were exposed to any antipsychotics within 28 days or 5 half-lives before the baseline visit, whichever was less, were excluded.
MDD
Two randomized, double‑blind, placebo‑controlled, phase 3 studies (studies 501 and 502) evaluated the efficacy and safety of CAPLYTA adjunctive to ADT in patients with MDD who had an inadequate response to ADT.17-20
  • Study 501: patients (N=485) were randomized to receive CAPLYTA 42 mg + ADT or placebo + ADT for 6 weeks.
  • Study 502: patients (N=480) were randomized to receive CAPLYTA 42 mg + ADT or placebo + ADT for 6 weeks.
  • Patients who took any antipsychotics after screening were excluded.
An open-label study (study 503) evaluated the safety and tolerability of CAPLYTA adjunctive to ADT in patients with MDD.21,22
  • Patients (N=809) received CAPLYTA 42 mg + ADT for 26 weeks.
  • Patients who took any antipsychotics during the study were excluded.
Abbreviations: ADT, antidepressant therapy; MDD, major depressive disorder; MDE, major depressive episode.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 11 February 2026.

 

References

Show
1 Data on File. CAPLYTA. Clinical Study Report of Study 005. Intra-Cellular Therapies, Inc; 2015.  
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.  
3 Data on File. CAPLYTA. Clinical Study Report of Study 301. Intra-Cellular Therapies, Inc; 2016.  
4 Data on File. CAPLYTA. Clinical Study Report of Study 302. Intra-Cellular Therapies, Inc; 2017.  
5 Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020;77(4):349-358.  
6 Data on File. CAPLYTA. Clinical Study Report of Study 303. Intra-Cellular Therapies, Inc; 2025.  
7 Correll CU, Vanover KE, Davis RE, et al. Safety and tolerability of lumateperone 42 mg: an open-label antipsychotic switch study in outpatients with stable schizophrenia. Schizophr Res. 2021;228:198-205.  
8 Data on File. CAPLYTA. Clinical Study Report of Study 401. Intra-Cellular Therapies, Inc; 2021.  
9 Data on File. CAPLYTA. Clinical Study Report of Study 402. Intra-Cellular Therapies, Inc; 2021.  
10 Data on File. CAPLYTA. Clinical Study Report of Study 403. Intra-Cellular Therapies, Inc; 2023.  
11 Data on File. CAPLYTA. Clinical Study Report of Study 404. Intra-Cellular Therapies, Inc; 2020.  
12 Correll C, Durgam S, Kozauer S, et al. Lumateperone monotherapy for major depressive episodes associated with bipolar disorder: efficacy and safety in a randomized placebo-controlled trial. Int Clin Psychopharmacol. 2026;41(2):120-129.  
13 Tohen M, Durgam S, Kozauer SG, et al. Long-term safety and tolerability of lumateperone 42 mg in patients with bipolar disorder: results from a 6-month open-label extension study. Int Clin Psychopharmacol. 2026;41(2):130-137.  
14 Suppes T, Durgam S, Kozauer SG, et al. Adjunctive lumateperone (ITI‐007) in the treatment of bipolar depression: results from a randomized placebo‐controlled clinical trial. Bipolar Disord. 2023;25(6):478-488.  
15 Durgam S, Kozauer SG, Earley WR, et al. 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.  
16 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.  
17 Data on File. CAPLYTA. Clinical Study Report of Study 501. Intra-Cellular Therapies, Inc; 2024.  
18 Data on File. CAPLYTA. Clinical Study Report of Study 502. Intra-Cellular Therapies, Inc; 2024.  
19 Durgam S, Earley WR, Kozauer SG, et al. 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.  
20 Durgam S, Earley WR, Kozauer SG, et al. 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.  
21 Data on File. CAPLYTA. Clinical Study Report of Study 503. Intra-Cellular Therapies, Inc; 2025.  
22 Earley WR, Durgam S, Kozauer SG, et al. Long-term adjunctive lumateperone treatment in major depressive disorder: results from a six-Month open-Label extension study. Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 27-30, 2025; Scottsdale, AZ.