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New CAPLYTA® (lumateperone) Phase 3 analyses evaluating efficacy in achieving remission in adjunctive major depressive disorder (aMDD) to be presented
SPRAVATO® (esketamine) effects on anhedonia in treatment-resistant depression (TRD) – Phase 3 data post-hoc analyses to be presented
Comparative tolerability of adjunctive seltorexant vs. adjunctive quetiapine XR in major depressive disorder (MDD) with insomnia symptoms – new Phase 3 metabolic analyses will also be presented
TITUSVILLE, N.J., Jan. 13, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 11 abstracts featuring new data on its robust portfolio and pipeline in neuropsychiatry will be presented at the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held from January 12-15, in Nassau, Bahamas. Presentations include the latest research from across the Company's neuropsychiatry portfolio, including major depressive disorder (MDD) and treatment-resistant depression (TRD), as well as preclinical and translational neuropsychiatric research.
"At Johnson & Johnson, we are tackling the greatest unmet needs for patients living with depression, schizophrenia and bipolar disorder – with the ultimate goal of remission from disease," said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. "Our data at ACNP this year showcases how we are boldly advancing our portfolio, from clinical findings on remission and tolerability to preclinical research on novel mechanisms and AI-driven precision tools, reflecting our commitment to redefining standards of care."
Key presentations include:
Johnson & Johnson will present the following posters at the ACNP meeting on January 14 at 5:00 – 7:00 p.m. ET and January 15 at 5:00 – 7:00 p.m. ET in the Exhibit Halls:
Poster # | Title |
Major Depressive Disorder | |
TH66 | Remission With Lumateperone 42 mg Adjunctive to Antidepressant Therapy in Patients With Major Depressive Disorder: Analysis of Short-Term and Long-Term Trials |
W124 | Efficacy of Lumateperone 42 mg for the Treatment of Major Depressive Disorder: Analysis of Demographic and Clinical Subgroups in a Phase 3 Randomized Placebo-Controlled Trial |
W122 | First Onset and Duration of Treatment-Emergent Adverse Events in Patients With Major Depressive Disorder Treated With Adjunctive Lumateperone 42 mg: A Pooled Analysis of 2 Randomized Placebo-Controlled Trials |
TH67 | Metabolic Profiles of Participants With Major Depressive Disorder With Insomnia Symptoms in a Phase 3 Trial of Seltorexant Versus Quetiapine Extended Release as Adjunctive Therapy |
Treatment-Resistant Depression | |
W123 | Short- and Long-Term Effects of Esketamine Nasal Spray on Anhedonia in Treatment-Resistant Depression: Post-Hoc Analyses From Two Phase 3 Studies |
Schizophrenia | |
TH268 | Characterization of Hippocampal E/I Balance in Novel Models of Schizophrenia and Pharmacological Intervention |
TH245 | Plasma Antipsychotic Levels in Remitted Patients with Schizophrenia Treated with Long-Acting Injectable Antipsychotics: Preliminary Results |
TU30 | Complement and Synaptic Protein Profiling in Schizophrenia CSF and Plasma: Analysis of the Psychiatric Biomarkers Network Cohort |
Neuroscience Discovery | |
TH41 | Human iPSC-Derived Oligodendrocytes Implicate Maturation Deficits in Neuropsychiatric Disease |
W117 | NAIO (Neuroscience and AI-Optimized Platform): A Multi-Modal Computational Platform for Informing Target and Indication Selection, Biomarker Readout, and Patient Stratification in CNS Drug Development |
TH202 | Selective GluN2D Inhibition Recapitulates Non-Selective NMDAR Antagonists Effects on Synaptic Plasticity in Rodents |
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.7,8 In 2023, approximately 22 million adults in the U.S. had at least one major depressive episode.9 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.10,11 As a result, responses to treatment vary widely. 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.12 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.13
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.14 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.15,16
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.17,18 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.18 Patients often cycle through multiple oral medications, waiting 4-6 weeks for potential relief.19 Based on the STAR*D study, after trying their third oral antidepressant, approximately 86 percent of patients do not achieve remission.19
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, and 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.
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 in patients with depression.20 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 and insomnia.21,22 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.
ABOUT SPRAVATO®
SPRAVATO® (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration alone 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 79 markets and administered to more than 150,000 patients worldwide.
CAPLYTA® IMPORTANT SAFETY INFORMATION
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
Medicines like CAPLYTA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). CAPLYTA is not approved for treating people with dementia-related psychosis.
CAPLYTA and antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Patients and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when CAPLYTA or an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms to your healthcare provider immediately.
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).
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. Tell your healthcare provider 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 1-888-611-4824 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.
US-CAP-2500827
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for CAPLYTA.
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:
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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 medicine 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:
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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.
References:
SOURCE Johnson & Johnson

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