Johnson & Johnson to Present 24 Neuropsychiatry Data Sets at Psych Congress 2026
Johnson & Johnson (NYSE: JNJ) will present 24 abstracts featuring clinical trial data and real-world evidence from across its neuropsychiatry portfolio at the 2026 Psych Congress Annual Meeting, taking place September 15–19 in New Orleans, Louisiana. The presentations will highlight ongoing research across mood disorders, schizophrenia and other neuropsychiatric conditions, with a particular focus on areas where patients and healthcare professionals continue to face substantial treatment challenges.
Among the most significant presentations will be new pivotal Phase 3 data evaluating CAPLYTA® (lumateperone) for the acute treatment of manic episodes, including manic episodes with mixed features, associated with bipolar I disorder. Additional CAPLYTA data will examine its potential across bipolar depression and major depressive disorder (MDD), including analyses of depressive symptoms, remission, patient subgroups and metabolic outcomes.
Johnson & Johnson will also present new analyses involving SPRAVATO® (esketamine) CIII nasal spray, including real-world evidence evaluating its impact on anhedonia, a core symptom of depression that can be difficult to treat and is associated with poorer outcomes.
The company’s Psych Congress program will further feature clinical and real-world evidence related to long-acting injectable (LAI) treatments, as well as Phase 3 and real-world research involving seltorexant in patients with MDD and insomnia symptoms.
Together, the presentations demonstrate Johnson & Johnson’s continued efforts to generate evidence across multiple stages of psychiatric treatment, from pivotal clinical development programs to real-world studies examining treatment patterns, patient outcomes and healthcare utilization.
New Phase 3 Data for CAPLYTA in Bipolar Mania
One of the key highlights of Johnson & Johnson’s Psych Congress presence will be new data from a pivotal Phase 3 study evaluating CAPLYTA in patients experiencing manic episodes or manic episodes with mixed features associated with bipolar I disorder.
Bipolar I disorder is characterized by episodes of mania that can significantly disrupt mood, behavior, functioning and quality of life. Manic episodes may involve elevated or irritable mood, increased activity or energy and other significant behavioral and cognitive changes. When manic symptoms occur alongside depressive symptoms, patients may experience mixed features, which can further complicate treatment.
The new Phase 3 findings are expected to provide additional evidence regarding the efficacy and safety profile of CAPLYTA in the acute treatment of these patients.
The presentation adds to a broader body of CAPLYTA research across mood disorders. Johnson & Johnson will also present several analyses examining CAPLYTA as adjunctive treatment in MDD.
These analyses will cover a range of outcomes, including depressive symptoms, remission and responses among specific patient subgroups. Additional research will evaluate metabolic outcomes, an area of importance in psychiatric treatment given that metabolic health can influence long-term treatment decisions and patient management.
By presenting data across multiple indications and patient populations, Johnson & Johnson aims to provide clinicians with a broader understanding of CAPLYTA’s clinical profile and its potential role across different mood disorder treatment settings.
Real-World Evidence Examines CAPLYTA Treatment Patterns
In addition to controlled clinical trial data, Johnson & Johnson will present new real-world evidence examining treatment patterns among patients with bipolar depression who receive CAPLYTA.
The study will provide insights into how the medicine is used in routine clinical practice, including treatment dosing and duration.
Real-world evidence can complement findings from randomized clinical trials by showing how therapies are used outside the controlled environment of clinical research. Such information can help researchers and clinicians understand treatment persistence, prescribing patterns and the practical experience of patients receiving therapy in everyday healthcare settings.
For bipolar depression, treatment management can be particularly complex because clinicians must consider both current depressive symptoms and the broader course of bipolar illness. Evidence regarding treatment patterns may therefore provide additional context for clinical decision-making.
Johnson & Johnson’s presentation of these findings alongside pivotal clinical trial results reflects the company’s strategy of combining traditional clinical development with evidence generated from real-world patient populations.
SPRAVATO Research Focuses on Anhedonia
Another important area of Johnson & Johnson’s Psych Congress program will be new analyses examining SPRAVATO® (esketamine) CIII nasal spray and its effect on anhedonia.
Anhedonia refers to a reduced ability to experience pleasure or interest in activities that would normally be rewarding. It is considered a core symptom of depression and can be particularly persistent even when other depressive symptoms improve.
Johnson & Johnson said the new analyses will examine real-world evidence concerning the impact of SPRAVATO on anhedonia.
The focus on anhedonia is clinically relevant because residual symptoms can contribute to ongoing impairment and may influence the overall trajectory of depression treatment. Patients whose symptoms do not fully resolve can continue to experience significant effects on social functioning, work, relationships and quality of life.
By examining the effect of SPRAVATO on specific depressive symptoms rather than focusing exclusively on overall depression scores, the analyses may offer additional insight into how treatment affects different dimensions of the disease.
Johnson & Johnson noted that anhedonia has been associated with poorer treatment outcomes, reinforcing the importance of investigating therapeutic approaches that may address this challenging component of depression.
Long-Acting Injectable Research in Schizophrenia
The Psych Congress presentations will also include real-world studies examining long-acting injectable treatments in schizophrenia.
One analysis will evaluate schizophrenia-related hospitalizations among young dual-eligible patients before initiation of an LAI and the subsequent risk of relapse. Another study will examine treatment satisfaction associated with LAIs.
Long-acting injectable medicines are designed to provide sustained medication delivery over an extended period and can play an important role in the management of conditions in which adherence to daily oral treatment may be challenging.
Hospitalization and relapse represent important outcomes in schizophrenia care. Recurrent episodes can have substantial consequences for patients, families and healthcare systems, while hospitalization may signal significant deterioration in symptoms or functioning.
Real-world analyses examining outcomes before and after LAI initiation can provide useful information about treatment patterns and disease management in clinical populations.
The treatment-satisfaction research adds another dimension by considering the patient experience. Understanding how patients perceive LAI treatment can help clinicians weigh the potential benefits and challenges of different treatment approaches when developing individualized care plans.
Seltorexant Data Address MDD and Insomnia Symptoms
Johnson & Johnson will also highlight clinical and real-world research involving seltorexant in MDD with insomnia symptoms.
Depression and insomnia frequently occur together, creating additional challenges for diagnosis and treatment. Sleep disturbances can contribute to functional impairment and may complicate the management of depressive symptoms.
The seltorexant presentations will include real-world data examining disease burden, patient management and treatment outcomes among people with MDD and insomnia symptoms.
These studies are intended to provide insight into the clinical characteristics and treatment experiences of patients dealing with this combination of conditions.
The research is particularly relevant because psychiatric disorders often involve multiple overlapping symptoms rather than a single isolated clinical problem. Sleep disturbances, mood symptoms, anxiety, cognitive difficulties and reduced functioning can occur together, making treatment selection and evaluation more complex.
Real-world evidence can help illustrate how these challenges are managed in everyday clinical practice and may identify areas where additional treatment strategies are needed.
Addressing Complex and Overlapping Psychiatric Symptoms
Jane Tiller, MD, vice president and global head of Development, Neuroscience, at Johnson & Johnson, emphasized the complexity faced by people living with neuropsychiatric disorders.
“People living with neuropsychiatric disorders often face complex, overlapping symptoms that can make identification, treatment selection and long-term management especially challenging,” Tiller said.
She added that Johnson & Johnson is advancing clinical and real-world evidence across its portfolio and pipeline with the goal of supporting progress in psychiatry and helping clinicians make more informed treatment decisions.
The company’s presentation strategy at Psych Congress reflects this approach. Rather than focusing on a single disease or therapy, the 24 abstracts span multiple psychiatric conditions and evidence types.
The program includes pivotal Phase 3 clinical trial results, analyses of specific symptoms and patient subgroups, metabolic assessments, real-world treatment patterns, hospitalization outcomes, relapse risk, treatment satisfaction and disease burden.
Combining Clinical Trials With Real-World Evidence
The breadth of Johnson & Johnson’s presentations illustrates the increasing importance of combining evidence generated through randomized clinical trials with data collected from routine clinical practice.
Pivotal clinical trials are essential for establishing efficacy and safety under defined study conditions. Real-world studies can subsequently help provide additional information about how therapies perform across broader patient populations and how they are incorporated into everyday treatment pathways.
For psychiatric disorders, this distinction can be particularly important. Patients encountered in routine practice may have multiple diagnoses, varying levels of disease severity, previous treatment exposure and other factors that can make their clinical experience different from that of participants enrolled in controlled trials.
Johnson & Johnson’s Psych Congress program therefore provides a broad look at its research strategy across neuropsychiatry, combining controlled clinical evidence with real-world findings.
Educational Programs and Interactive Exhibits
Beyond the 24 abstracts, Johnson & Johnson will support a range of educational activities at Psych Congress 2026.
The company said its activities will include educational programs, in-booth presentations and training opportunities for meeting attendees. These initiatives will provide additional opportunities for healthcare professionals to engage with research and clinical information from across the company’s neuropsychiatry portfolio.
Among the planned activities will be interactive visualizations of PRIDE LAI data. The company will also share the latest CAPLYTA schizophrenia findings and network meta-analysis (NMA) results.
Network meta-analyses can help researchers compare multiple treatment options by synthesizing evidence across clinical studies, potentially providing additional context for understanding how different therapies compare within a broader treatment landscape.
The inclusion of these resources alongside clinical and real-world presentations reflects Johnson & Johnson’s emphasis on providing healthcare professionals with evidence that can support clinical decision-making.
Continued Focus on Unmet Needs in Psychiatry
The 2026 Psych Congress presentations come at a time when significant unmet needs remain across neuropsychiatric conditions. Although treatment options have expanded in recent years, many patients continue to experience persistent symptoms, inadequate responses, adverse effects or difficulties maintaining long-term treatment.
Conditions such as bipolar disorder, MDD and schizophrenia can also involve complex symptom profiles that vary considerably between individuals. As a result, clinicians often need to balance efficacy, tolerability, patient preferences, comorbidities and long-term disease management when selecting treatment.
Johnson & Johnson’s research program is aimed at addressing some of these challenges by investigating therapies across different disease states and symptom domains.
The new CAPLYTA Phase 3 data in bipolar mania represent an important addition to the company’s research across bipolar disorder, while the additional CAPLYTA studies in MDD and bipolar depression broaden the evidence base around the medicine.
Meanwhile, the SPRAVATO analyses targeting anhedonia focus on a specific and often difficult-to-treat symptom of depression. The LAI studies address treatment patterns and patient experiences in schizophrenia, while seltorexant research explores the intersection between MDD and insomnia symptoms.
Data to Be Presented at Psych Congress 2026
Johnson & Johnson’s 24 abstracts will be presented during the 2026 Psych Congress Annual Meeting in New Orleans from September 15–19.
The company said the full list of presentations is available through its corporate website, with the program covering CAPLYTA, SPRAVATO, long-acting injectable treatments and seltorexant.
The meeting will provide an opportunity for clinicians, researchers and other psychiatric healthcare professionals to review new findings across Johnson & Johnson’s neuropsychiatry portfolio.
With pivotal Phase 3 results, symptom-focused analyses and real-world evidence being presented together, the company’s presence at Psych Congress 2026 underscores its continued focus on advancing research across mood disorders and schizophrenia while addressing practical challenges in long-term psychiatric care.
Overall, the data presentations are intended to expand understanding of treatment options and patient outcomes across several important neuropsychiatric conditions. Johnson & Johnson said its broader objective is to contribute evidence that can help clinicians make more informed decisions as they manage complex and often overlapping symptoms in patients living with psychiatric disorders.
ABOUT BIPOLAR MANIA
Bipolar disorder 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.17,18 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, as well as symptoms including grandiosity, decreased need for sleep, racing thoughts, distractibility, and risk-taking behavior.19 These noticeable 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.20
ABOUT MAJOR DEPRESSIVE DISORDER (MDD)
MDD is one of the most common psychiatric disorders and a leading cause of disability worldwide, impacting an estimated 332 million people—or about 4 percent of the population.21,22,23 In 2023, approximately 22 million adults in the U.S. had at least one major depressive episode.24 While depression is typically treated with a “one-size-fits-all” approach, no two cases are the same. MDD is a complex, heterogeneous disorder involving multiple regions of the brain and presenting with as many as 256 unique symptom combinations.
As a result, responses to treatment vary widely.25,26 Only 1 in 3 patients reach remission with their first antidepressant—and rates continue to decline further with each subsequent treatment, leaving many to spend years cycling through multiple treatments trying to find complete, sustained symptom relief.27 Moreover, MDD is a risk factor for the development and worsening of a range of comorbidities, illustrating the importance of integrating mental and general health care.28
Anhedonia, a loss of interest or pleasure in previously enjoyed activities, is one of two defining symptoms of a major depressive episode.29 Anhedonia is associated with poorer treatment outcomes, including lower remission rates, greater functional impairment, and higher suicide risk.30 Notably, 40-70% of people with MDD experience anhedonia.30
MDD often includes sleep disturbances such as insomnia or hypersomnia, with approximately 60 percent of MDD patients experiencing clinically relevant insomnia symptoms despite being on an SSRI/SNRI.31 Disturbed sleep and insomnia symptoms have a significant impact on a patient’s quality of life and exacerbate the risk of depressive relapse and suicide.32,33
Approximately one-third of adults with MDD will not respond to oral antidepressants alone and are considered to have treatment-resistant depression (TRD), which is often defined as inadequate response to two or more oral antidepressants that were administered at an adequate dose for an adequate duration.34,35
TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.35 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.36 Based on the STAR*D study, after their third line of treatment, approximately 86 percent of patients do not achieve remission.36
ABOUT SCHIZOPHRENIA
Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects up to an estimated 2.8 million adults in the United States yet remains widely misunderstood and insufficiently treated.37 Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behavior are common.38
Evidence shows that the first three to five years after diagnosis — “the critical period” — from symptom onset are key for a patient’s treatment, as this is when the condition progresses most rapidly.39,40 A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, is critical in delaying the time to relapse for adults with schizophrenia.41
ABOUT CAPLYTA® (lumateperone)
CAPLYTA® 42 mg is an oral, once daily atypical antipsychotic approved in adults as an adjunctive therapy with antidepressants for major depressive disorder (MDD), schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, or as adjunctive therapy with lithium or valproate.
While the mechanism of action of CAPLYTA® is unknown, the efficacy of CAPLYTA® could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and partial agonist activity at central dopamine D2 receptors.
A supplemental New Drug Application (sNDA) for CAPLYTA® with long-term data evaluating the safety and efficacy of the medication for delayed time to relapse in schizophrenia was recently approved by the U.S. Food and Drug Administration. The medication is also being studied for other neuropsychiatric disorders. CAPLYTA® is not FDA-approved for these disorders.
ABOUT SPRAVATO® (esketamine) CIII NASAL SPRAY
SPRAVATO® is approved by the U.S. Food and Drug Administration as monotherapy or in conjunction with an oral antidepressant for adults with MDD when they have inadequate response to at least two oral antidepressants (TRD) and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior in conjunction with an oral antidepressant.
It is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than traditional antidepressants by acting on a pathway in the brain that affects glutamate. The mechanism by which esketamine exerts its antidepressant effect is unknown. To date, SPRAVATO® has been approved in over 70 markets and administered to more than 250,000 patients worldwide.
ABOUT J&J’S SCHIZOPHRENIA LONG-ACTING INJECTABLE (LAI) PORTFOLIO
Johnson & Johnson’s portfolio of long-acting injectable (LAI) offerings for schizophrenia offers a varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available, including INVEGA SUSTENNA® (1-month paliperidone palmitate), INVEGA TRINZA® (3-month paliperidone palmitate), and INVEGA HAFYERA® (6-month paliperidone palmitate), all of which are administered in a clinical setting by a medical professional.42,43,44
ABOUT SELTOREXANT
Seltorexant, an investigational first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant selectively antagonizes the orexin-2 receptors, potentially improving mood symptoms associated with depression and restoring sleep without next-day sedation.45
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.46,47 Seltorexant is the only investigational therapy under study for the treatment of MDD that is believed to work by normalizing the overactivation of the orexin-2 receptors, thereby targeting the underlying biology that contributes to depression and insomnia symptoms.