SUMMARY

• CAPLYTA is indicated for: treatment of schizophrenia in adults; treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate; and adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.¹ CAPLYTA is not approved for the treatment of generalized anxiety disorder.
• Call a healthcare provider right away if you or your family member experience new or worsening anxiety.
• Durgam et al (2025)² conducted a 6-week, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, phase 3 study (study 501) to assess the efficacy and safety of CAPLYTA 42 mg adjunctive to antidepressant therapy (ADT) in patients with MDD who had an inadequate response to ADT.
  • Generalized Anxiety Disorder-7 item (GAD-7) Total score least squares (LS) mean change from baseline to day 43 was -4.7 (standard error [SE], 0.26) for CAPLYTA 42 mg+ADT (n=241) vs -3.1 (0.26) for placebo+ADT (n=243) in the intent-to-treat (ITT) population (P<0.0001).
• Durgam et al (2025)³ conducted a post hoc analysis of study 501 to evaluate the efficacy of adjunctive treatment of CAPLYTA in patients with MDD and anxious distress (CAPLYTA 42 mg+ADT, n=109; placebo+ADT, n=98).
  • CAPLYTA 42 mg+ADT showed a statistically significant improvement in the GAD-7 Total score compared to placebo+ADT at day 43 (LS mean difference=-3.2; effect size=-0.88; P<0.0001) in patients with anxious distress.

PRODUCT LABELING

CAPLYTA is an atypical antipsychotic indicated for: treatment of schizophrenia in adults; treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate; and adjunctive therapy with antidepressants for the treatment of MDD in adults.¹ 

CLINICAL DATA

Phase 3 Study

Durgam et al (2025)² conducted a randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study (study 501) to assess the efficacy and safety of CAPLYTA adjunctive to ADT in patients with MDD who had an inadequate response to ADT. Patients were randomized (1:1) to receive either CAPLYTA 42 mg (n=242) or placebo (n=243) as adjunctive treatment to ADT for 6 weeks; this was followed by a 1-week safety follow-up period (See Figure: Study Design for Study 501).

• CAPLYTA+ADT showed a statistically significant reduction in the GAD-7 Total score compared to placebo+ADT.²
• The baseline mean±standard deviation (SD) GAD-7 Total score was 9.9±5.00 for CAPLYTA 42 mg+ADT and 9.6±5.03 for placebo+ADT.
  • In the ITT population, the LS mean (SE) change from baseline to day 22 was -3.2 (0.26) for CAPLYTA 42 mg+ADT (n=241) vs -2.2 (0.26) for placebo+ADT (n=243). The LS mean difference was -1.0 (95% confidence interval [CI]: -1.65 to -0.28; P=0.0061).⁴
  • In the ITT population, the LS mean (SE) change from baseline to day 43 was -4.7 (0.26) for CAPLYTA 42 mg+ADT (n=241) vs -3.1 (0.26) for placebo+ADT (n=243). The LS mean difference was -1.6 (95% CI: -2.31 to -0.93; P<0.0001), with an effect size of -0.43.²

Durgam et al (2025)³ conducted a post hoc analysis of study 501 to evaluate the efficacy of adjunctive treatment of CAPLYTA in patients with MDD and anxious distress (CAPLYTA 42 mg+ADT, n=109; placebo+ADT, n=98).

• The baseline mean±SD GAD-7 Total score was 11.9±4.36 for CAPLYTA 42 mg+ADT and 11.3±4.22 for placebo+ADT.
  • CAPLYTA 42 mg+ADT showed a statistically significant improvement in the GAD-7 Total score compared to placebo+ADT at day 43 (LS mean difference=-3.2; effect size=-0.88; P<0.0001) in patients with anxious distress.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 10 November 2025.