Johnson & Johnson to Present Phase 3 CAPLYTA Data Across Bipolar Mania, Depression and Schizophrenia at Psych Congress 2026
核心洞察
Johnson & Johnson announced it will present new neuropsychiatry data spanning bipolar mania, major depressive disorder (搜索) and schizophrenia (搜索) at Psych Congress 2026, held September 15-19, 2026.
Presentations include pivotal Phase 3 CAPLYTA (lumateperone) data in bipolar I mania and pooled analyses of adjunctive lumateperone 42 mg in major depressive disorder (搜索).
Additional data cover SPRAVATO (esketamine) nasal spray anhedonia (搜索) outcomes in treatment-resistant depression (搜索) and real-world studies of J&J's long-acting injectable schizophrenia (搜索) portfolio.
Johnson & Johnson will spotlight new neuropsychiatry data across bipolar mania, major depressive disorder (搜索) (MDD) and schizophrenia (搜索) at Psych Congress 2026, the company announced on September 8, 2026, ahead of the meeting scheduled for September 15-19, 2026. The presentations include pivotal Phase 3 data for CAPLYTA (lumateperone) and span clinical research across different stages and types of mental illness, reflecting an increasing focus on treatments addressing unmet needs in brain-related psychiatry.
Phase 3 Data in Bipolar I Mania
Among the presentations is a double-blind, placebo-controlled, randomized Phase 3 trial of lumateperone for manic episodes, or manic episodes with mixed features, in bipolar I disorder. Bipolar disorder (搜索) affects an estimated 37 million people worldwide — approximately 1 in 200 individuals — with 4.4% of U.S. adults experiencing the condition in their lifetime.
Mania, a key feature of bipolar I disorder, is characterized by at least a week-long period of elevated or irritable mood and/or increased energy, along with symptoms including grandiosity, decreased need for sleep, racing thoughts, distractibility and risk-taking behavior. These behavioral changes often differ markedly from an individual's baseline and are frequently first recognized by those close to them; in severe cases, manic episodes may require hospitalization for safety and treatment.
Additional lumateperone analyses in bipolar depression include an electronic health records study of changes in mean total PHQ-9 score among U.S. patients and a real-world analysis of lumateperone dosing patterns and treatment duration.
Major Depressive Disorder and Anhedonia
In MDD, J&J will present a pooled analysis of efficacy across patient-reported depression symptoms with adjunctive lumateperone 42 mg, a demographic and clinical subgroup efficacy analysis from a Phase 3 randomized placebo-controlled trial, and an analysis of remission in short- and long-term trials. A pooled analysis of two randomized, placebo-controlled trials will examine the metabolic profile of adjunctive lumateperone 42 mg in MDD, alongside a U.S. cost-per-remitter analysis comparing lumateperone with cariprazine.
MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people — about 4 percent of the population. In 2023, approximately 22 million U.S. adults had at least one major depressive episode. Only 1 in 3 patients reach remission with their first antidepressant, and rates decline further with each subsequent treatment. Based on the STAR*D study, after a third line of treatment approximately 86 percent of patients do not achieve remission.
Anhedonia (搜索) — a loss of interest or pleasure in previously enjoyed activities — is one of two defining symptoms of a major depressive episode and is associated with poorer treatment outcomes, including lower remission rates, greater functional impairment and higher suicide risk; 40-70% of people with MDD experience it. Approximately 60 percent of MDD patients experience clinically relevant insomnia (搜索) symptoms despite being on an SSRI/SNRI.
SPRAVATO (esketamine) CIII nasal spray data at the congress include a post hoc analysis of Montgomery-Åsberg Depression Rating Scale anhedonia (搜索) factor scores following esketamine nasal spray monotherapy in adults with treatment-resistant depression (搜索) (TRD), and findings from the Ventura real-world evidence study on anhedonia and functional outcomes. Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have TRD, often defined as inadequate response to two or more oral antidepressants administered at an adequate dose for an adequate duration. SPRAVATO is approved as monotherapy or in conjunction with an oral antidepressant for adults with MDD with inadequate response to at least two oral antidepressants, and for depressive symptoms in adults with MDD with acute suicidal ideation or behavior in conjunction with an oral antidepressant. It has been approved in over 70 markets and administered to more than 250,000 patients worldwide.
Schizophrenia: Long-Acting Injectables and Relapse
J&J's schizophrenia (搜索) presentations include an analysis of the association between schizophrenia-related hospitalization before long-acting injectable (LAI) antipsychotic initiation and outcomes among young dual eligibles, and a study of treatment satisfaction, quality of life, satisfaction with participation in social roles, and caregiver burden in adults treated with paliperidone palmitate LAIs. The company will also host interactive visualizations of PRIDE LAI data and present the latest CAPLYTA schizophrenia and network meta-analysis findings.
Schizophrenia (搜索) affects up to an estimated 2.8 million adults in the United States. Evidence shows the first three to five years after diagnosis — "the critical period" from symptom onset — are key for treatment, as this is when the condition progresses most rapidly. J&J's LAI portfolio includes INVEGA SUSTENNA (1-month paliperidone palmitate), INVEGA TRINZA (3-month paliperidone palmitate) and INVEGA HAFYERA (6-month paliperidone palmitate), all administered in a clinical setting by a medical professional.
A supplemental New Drug Application for CAPLYTA with long-term data evaluating safety and efficacy for delayed time to relapse in schizophrenia (搜索) was recently approved by the U.S. Food and Drug Administration (搜索). CAPLYTA 42 mg is an oral, once-daily atypical antipsychotic approved in adults as an adjunctive therapy with antidepressants for MDD, for schizophrenia, and for depressive episodes associated with bipolar I or II disorder as monotherapy or as adjunctive therapy with lithium or valproate. While its mechanism of action is unknown, efficacy could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors.
Seltorexant and the Insomnia-Depression Interface
Seltorexant, an investigational first-in-class therapy, is a selective antagonist of the human orexin-2 receptor (搜索) being developed as an adjunctive treatment for adults with MDD with insomnia (搜索) symptoms. When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations including insomnia and excessive cortisol release, which may contribute to depression. Seltorexant is described as the only investigational therapy under study for MDD believed to work by normalizing overactivation of orexin-2 receptors, potentially improving mood symptoms and restoring sleep without next-day sedation.
Congress presentations also address the insomnia (搜索)-depression relationship, including a real-world evidence study of cardiometabolic event incidence among adults with MDD with and without insomnia symptoms, an analysis of insomnia symptoms in MDD and their association with healthcare resource use and cardiovascular and metabolic conditions using National Health & Nutrition Examination Survey data, and a study of insomnia management in MDD through patient-provider discourse.
Interpretation and Industry Implications
According to Precedence Research, the neuropsychiatry data could lead to greater pharmaceutical investment in treatments for serious psychiatric disorders, with research focus on the competitive edge of bipolar mania, depression and schizophrenia (搜索) as companies develop therapies offering better efficacy and tolerability. Should the data result in successful regulatory approvals and clinical acceptance, they could increase competition in neuropsychiatry and promote innovation. The industry is expected to closely watch the durability of treatment effects, safety results, and how new therapies differ from existing infrastructure.
From an expert perspective cited by Precedence Research, the significance of the data lies in covering three key areas of psychiatric medicine with a great need for treatment, though the findings should be carefully interpreted until backed by peer-reviewed evidence and longer-term clinical experience. The most important issues to address are the size and length of treatment effects, safety, tolerability, and which patient groups are most likely to benefit. New treatments may also carry implications for healthcare payers, given that serious mental health conditions demand long-term management and can result in high costs through medication, hospitalization and supportive care; payers evaluating such treatments will consider clinical effectiveness alongside treatment durability, quality of life, healthcare utilization and overall cost-effectiveness.
J&J will also support educational programs, in-booth presentations and training opportunities for attendees. The full list of data presentations is available on JNJ.com.