Johnson & Johnson spotlights new neuropsychiatry data across bipolar mania, depression and schizophrenia at Psych Congress 2026

PR Newswire

TITUSVILLE, N.J., Sept. 8, 2026

First presentation of pivotal Phase 3 CAPLYTA ® data in adults with bipolar mania underscores the asset's potential across mood disorders

New SPRAVATO ® analyses and schizophrenia research emphasize a focus on complex, high-burden neuropsychiatric conditions

TITUSVILLE, N.J., Sept. 8, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that 24 abstracts featuring clinical data and real-world evidence across the neuropsychiatry portfolio will be presented at the 2026 Psych Congress Annual Meeting (September 15-19, New Orleans, LA).

Among the featured presentations are new pivotal Phase 3 data evaluating the efficacy and safety of CAPLYTA® (lumateperone) in bipolar mania, alongside additional CAPLYTA® data across bipolar depression and major depressive disorder that further reinforce the breadth of studies for the asset across mood disorders. Data evaluating the effect of SPRAVATO® (esketamine) CIII nasal spray on depressive symptoms such as anhedonia, and Phase 3 clinical trial data for seltorexant in major depressive disorder (MDD) with insomnia symptoms will also be presented. Together, the presentations reflect the Company's continued commitment to advancing research across mood disorders, with a focus on areas where patients and clinicians still face significant treatment challenges.

"People living with neuropsychiatric disorders often face complex, overlapping symptoms that can make identification, treatment selection and long-term management especially challenging," said Jane Tiller, MD, Vice President, Global Head of Development, Neuroscience, Johnson & Johnson. "By advancing clinical and real-world evidence across our portfolio and pipeline, we aim to help move psychiatry forward so that clinicians can continue to make more informed decisions for the patients they serve."

Psych Congress Annual Meeting highlights include:

The full list of Johnson & Johnson data presentations at Psych Congress is available on JNJ.com. The Company will also support a variety of educational programs, in-booth presentations and training opportunities for attendees, including interactive visualizations of PRIDE LAI data, and the latest CAPLYTA® schizophrenia and network meta-analysis (NMA) findings.

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.

CAPLYTA® IMPORTANT SAFETY INFORMATION

What is CAPLYTA (lumateperone)?

CAPLYTA® (lumateperone) is a prescription medicine used in adults along with an antidepressant to treat major depressive disorder (MDD); to treat depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression) alone or with lithium or valproate; or to treat schizophrenia. It is not known if CAPLYTA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CAPLYTA?

• thoughts about suicide or dying     

• acting aggressive, being angry or violent 

• panic attacks

• new or worse depression 

• new or worse anxiety

• new or worse irritability  

• feeling very agitated or restless   

• suicide attempts 

• acting on dangerous impulses

• trouble sleeping

• an extreme increase in activity and talking (mania)

• other unusual changes in behavior or mood

Do not take CAPLYTA if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (e.g., rash, itching, hives, swelling of the tongue, lip, face, or throat).

What are the possible side effects of CAPLYTA?

CAPLYTA may cause serious side effects, including:

The most common side effects of CAPLYTA include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea.

These are not all the possible side effects of CAPLYTA.

Before taking CAPLYTA, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or a stroke, high or low blood pressure, diabetes, or high blood sugar, problems with cholesterol, have or have had a low white blood cell count, seizures (convulsions), or kidney or liver problems.

CAPLYTA may cause fertility problems in females and males. You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking CAPLYTA. There is a pregnancy registry for females who are exposed to CAPLYTA during pregnancy. CAPLYTA may cause abnormal involuntary movements and/or withdrawal symptoms in newborn babies exposed to CAPLYTA during the third trimester. Talk to your healthcare provider if you breastfeed or are planning to breastfeed as CAPLYTA passes into breast milk.

Tell your healthcare provider about all the medicines you're taking. CAPLYTA may affect the way other medicines work, and other medicines may affect how CAPLYTA works, causing possible serious side effects. Do not start or stop any medicines while taking CAPLYTA without talking to your healthcare provider. You are encouraged to report negative side effects of prescription drugs. Contact Intra-Cellular Therapies, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CAPLYTA is available in 42 mg, 21 mg, and 10.5 mg capsules.

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for CAPLYTA.

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INVEGA SUSTENNA®, INVEGA TRINZA®, INVEGA HAFYERA® IMPORTANT SAFETY INFORMATION 

INDICATIONS 

INVEGA HAFYERA® (6-month paliperidone palmitate) is a prescription medicine given by injection every 6 months by a healthcare professional and used to treat schizophrenia. INVEGA HAFYERA® is used in adults who have been treated with either: 

INVEGA TRINZA® is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been adequately treated with INVEGA SUSTENNA® for at least 4 months. 

INVEGA SUSTENNA® is a prescription medicine given by injection by a healthcare professional.  

INVEGA SUSTENNA® is used to treat schizophrenia in adults. 

IMPORTANT SAFETY INFORMATION 

What is the most important information I should know about INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA®? 

INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: 

Do not receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® ingredients. 

Before you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:   

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® works. 

Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine. 

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls. 

How will I receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? 

What should I avoid while receiving INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? 

INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: 

The most common side effects of INVEGA HAFYERA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. 

The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. 

The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. 

Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist. 

Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088. 

General information about the safe and effective use of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® 

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. You can ask your pharmacist or healthcare professional for information about INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals. 

For more information, go to www.invegahafyera.com, www.invegatrinza.com or www.invegasustenna.com or call 1-800-526-7736. 

Please click to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional. 

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SPRAVATO® IMPORTANT SAFETY INFORMATION 

What is SPRAVATO® (esketamine) CIII nasal spray? 

SPRAVATO® is a prescription medicine used:

SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine.

It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®.

It is not known if SPRAVATO® is safe and effective in children. 

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SPRAVATO®? 

SPRAVATO® can cause serious side effects, including: 

Tell your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: 

  • thoughts about suicide or dying 
  • new or worse depression 
  • feeling very agitated or restless 
  • trouble sleeping (insomnia) 
  • acting aggressive, being angry or violent 
  • an extreme increase in activity and talking (mania) 

 

  • suicide attempts 
  • new or worse anxiety 
  • panic attacks 
  • new or worse irritability 
  • acting on dangerous impulses 
  • other unusual changes in behavior or mood 

 

Do not take SPRAVATO® if you: 

If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®. 

Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you: 

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking SPRAVATO® with certain medicines may cause side effects. 

Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. 

How will I take SPRAVATO®? 

What should I avoid while taking SPRAVATO®? 

Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO®?" 

What are the possible side effects of SPRAVATO®? 

SPRAVATO® may cause serious side effects including: 

See "What is the most important information I should know about SPRAVATO®?" 

Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®. 

Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. 

Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night. 

The most common side effects of SPRAVATO® include: 

  • feeling disconnected from yourself, your thoughts, feelings and things around you 
  • dizziness 
  • nausea 
  • feeling sleepy 
  • spinning sensation 
  • decreased feeling of sensitivity (numbness) 

 

  • feeling anxious 
  • lack of energy 
  • increased blood pressure 
  • vomiting 
  • feeling drunk 
  • headache 
  • feeling very happy or excited 

 

If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day. 

These are not all the possible side effects of SPRAVATO®. 

Call your doctor for medical advice about side effects. You may report side effects to Johnson & Johnson at 1-800-526-7736, or to the FDA at 1-800-FDA-1088. 

Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider. 

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About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed.

© Johnson & Johnson and its affiliates 2026. All rights reserved.

Cautions Concerning Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 related to product development and the potential benefits and treatment impact of CAPLYTA® (lumateperone), SPRAVATO® (esketamine) CIII nasal spray, and seltorexant. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

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