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CAPLYTA®

(lumateperone)

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CAPLYTA® (lumateperone)
Medical Information

CAPLYTA - Use in Patients with Obsessive-Compulsive Disorder

Last Updated: 04/30/2026

SUMMARY

  • Johnson and Johnson does not recommend the use of CAPLYTA in a manner that is inconsistent with the prescribing information.
  • Patients with confirmed diagnosis of obsessive-compulsive disorder (OCD) within 6 months of screening were excluded from CAPLYTA clinical trials for adjunctive use in major depressive disorder and bipolar depression.
    • Studies on use of CAPLYTA in patients with bipolar depression1-4
    • Studies on use of CAPLYTA in patients with major depressive disorder5,6
  • Naguy et al (2023)7 described the use of CAPLYTA 42 mg in a 15-year-old male patient with treatment-resistant OCD.
    • Following treatment with CAPLYTA 42 mg once daily, the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score improved down to 12 and the Clinical Global Impression-Improvement (CGI-I) score was 2.

CASE STUDY

Naguy et al (2024)7 described the case of a 15-year-old male with a treatment-resistant OCD.

  • Following psychiatric evaluation, the patient was administered fluvoxamine (up to 300 mg/day) with clonazepam (2 mg/day) for >2 months, with inadequate response and reports of agitation.
  • Treatment regimen was adjusted to sertraline 200 mg/day, clonazepam 2 mg/day, cognitive behavioral therapy, and risperidone 2 mg/day.
  • Patient was diagnosed with OCD with secondary depressive mood. Y-BOCS score was 32. Clomipramine 100 mg was added to his treatment regimen. On repeat Y-BOCS assessment, patient scored 30 and reported weight gain and increased serum prolactin levels. Risperidone was discontinued and sertraline 300 mg/day was added.
  • Following a hospital visit for unresolved symptoms, add on intravenous clomipramine, lithium 800 mg/day, aripriprazole 15 mg/day and buspirone 45 mg/day were trialed,
    Y-BOCS score was 31.
  • Patient started CAPLYTA 42 mg once daily at nighttime with dinner following a 2-week washout of all other medications except clonazepam 2 mg/day. After 1 month, Y-BOCS score was 12, and CGI-I score was 2.
  • CALYTA 42 mg was well tolerated, with normalization of prolactin levels, and significant weight loss.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 30 March 2026.

References

Show
1 Protocol for: Clinical trial evaluating ITI-007 (lumateperone) as a monotherapy for the treatment of bipolar depression. ClinicalTrials.gov. Accessed 2026-04-22. https://cdn.clinicaltrials.gov/large-docs/94/NCT02600494/Prot_000.pdf
2 Protocol for: A phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ITI-007 adjunctive to lithium or valproate in the treatment of patients with major depressive episodes associated with bipolar I or II disorder (bipolar depression). ClinicalTrials.gov. Accessed 2026-04-22. https://cdn.clinicaltrials.gov/large-docs/07/NCT02600507/Prot_000.pdf
3 Protocol for: A phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) or major depressive disorder. ClinicalTrials.gov. Accessed 2026-04-22. https://cdn.clinicaltrials.gov/large-docs/15/NCT04285515/Prot_000.pdf
4 Protocol for: A phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with bipolar I or II disorder (bipolar depression) conducted globally. ClinicalTrials.gov. Accessed 2026-04-22. https://cdn.clinicaltrials.gov/large-docs/76/NCT03249376/Prot_000.pdf
5 Protocol for: A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of lumateperone as adjunctive therapy in the treatment of patients with major depressive episodes. ClinicalTrials.gov. Accessed 2026-04-22. https://cdn.clinicaltrials.gov/large-docs/42/NCT04985942/Prot_000.pdf
6 Protocol for: A randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of lumateperone as adjunctive therapy in the treatment of patients with major depressive disorder. ClinicalTrials.gov. Accessed 2026-04-22. https://cdn.clinicaltrials.gov/large-docs/06/NCT05061706/Prot_000.pdf
7 Naguy A, Pridmore S, Abuzeid MY, et al. Lumateperone monotherapy for treatment-resistant obsessive-compulsive disorder in an adolescent. CNS Spectrums. 2024;29(1):4-5.