BEERSE, BELGIUM (10 October 2025) — Johnson & Johnson announced today that 17 abstracts featuring new clinical and real-world data will be presented at the annual European College of Neuropsychopharmacology (ECNP) Congress, taking place October 11-14 in Amsterdam, The Netherlands. Presentations include the latest research from across the Company’s neuropsychiatry portfolio, including major depressive disorder (MDD), treatment-resistant depression (TRD) and schizophrenia.
“MDD is a complex disorder that can manifest in different ways for each individual, and the traditional one-size-fits-all treatment approach often results in mixed patient outcomes,” said Bill Martin, Ph.D., Global Neuroscience Therapeutic Area Head, Johnson & Johnson Innovative Medicine. “At J&J, we are committed to advancing innovative and differentiated therapies through a targeted and patient-first approach, and our data at ECNP strongly reflects our relentless focus on this commitment.”
Key presentations include:
- New analysis of Phase 3 data evaluating the impact of investigational adjunctive lumateperone on sexual function in patients with MDD (Poster PS04-3102).1
- An oral presentation highlighting findings from a sub-group analysis of Phase 3 data evaluating the efficacy of adjunctive seltorexant, an investigational first-in-class therapy, compared with adjunctive quetiapine extended release (XR) in European Union and United Kingdom patients with MDD with insomnia symptoms.2
- Findings from a post-hoc analysis of the ESCAPE-TRD study examining the association between baseline patient characteristics and reaching remission with esketamine nasal spray versus quetiapine XR in patients with TRD (Poster PS02-1219).3
- Real-world safety data from the French ELLIPSE study of esketamine nasal spray (PS02-1111).4
- Results from a Delphi research study outlining expert consensus recommendations of European psychiatrists on key decision-making factors for continuation of esketamine nasal spray treatment in patients with TRD (Poster PS04-3215).5
Johnson & Johnson will present the following posters at ECNP Congress on October 12 from 8:00 – 8:30 a.m. CET (e-posters), October 13 from 12:35 – 2:00 p.m. CET and October 14 from 12:35 – 2:00 p.m. CET.
| Poster # | Title |
| Major Depressive Disorder | |
| EP03-0245 | Adjunctive Lumateperone 42 mg Treatment in Major Depressive Disorder: Efficacy in Anhedonia and Across Broad Range of Depressive Symptoms |
| PS03-2109 | Efficacy of Adjunctive Lumateperone 42 mg Treatment Across Depression and Anhedonia Symptoms in Major Depressive Disorder |
| PS04-3102 | Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder |
| EP03-0243 | Long-Term Adjunctive Lumateperone Treatment in Major Depressive Disorder: Results From a Six-Month Open-Label Extension Study |
| PS03-2108 | Beyond Inflammation: Unveiling Novel Molecular Mechanisms in Major Depressive Disorder and Antidepressant Response in a Cohort Stratified by Inflammatory Status |
| PS02-1123 | Seltorexant: A Safe and Well-Tolerated Adjunctive Treatment for Adolescent Major Depressive Disorder With Comparable Pharmacokinetics to Adults |
| PS03-2143 | Factors Associated With Long-Term Hypnotics Use in Depression |
| Oral Presentation | Developments in Adjunctive Treatment: Seltorexant Versus Quetiapine in Managing Major Depressive Disorder With Insomnia Symptoms |
| Treatment-Resistant Depression | |
| PS02-1220 | Efficacy and Safety of 4 Months of Treatment With Esketamine Nasal Spray Monotherapy in Adult Patients With Treatment-Resistant Depression |
| PS01-0124 | Early Dose Management and Up-Titration of Esketamine in the Double-Blind Induction Phase of the Randomized, Active-Controlled, Phase 3 TRANSFORM-2 Study |
| PS04-3215 | Expert Consensus on Decision-Making Factors for Continuation of Esketamine Nasal Spray in Treatment-Resistant Depression: A Delphi Method |
| PS02-1216 | ECHO: Study Design and Baseline Characteristics of a Non-Interventional Cohort Study of Esketamine Nasal Spray in Treatment-Resistant Depression |
| PS02-1219 | Patient Characteristics Associated With Relative Benefit of Esketamine Nasal Spray Versus Quetiapine Extended Release on Achieving Remission in ESCAPE-TRD Study |
| PS02-1111 | Evolution of Clinical Dimensions and Safety in Patients With Major Depressive Disorder Treated by Esketamine: The French Real-World ELLIPSE Study |
| PS01-0076 | Prevalence, Incidence and Therapy of (Treatment-Resistant) Depression in Germany: A Sickness Funds Analysis |
| Schizophrenia | |
| PS01-0220 | Impact of Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables on Clinical and Psychosocial Outcomes in Rwandan Patients With Schizophrenia |
| PS04-3104 | Lumateperone For The Prevention of Relapse in Patients with Schizophrenia: Results From a Double-Blind, Placebo-Controlled, Randomized Withdrawal, Phase 3 Trial |
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 and 40 million people in the WHO European Region.6,7,8 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.9,10 As a result, responses to treatment vary widely. With current standard-of-care oral antidepressants, 2 in 3 people living with MDD continue to experience residual or persistent symptoms.11 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.12
Insomnia is one of the most common symptoms of MDD, affecting more than 80 percent of people living with the condition.13,14 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 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.20
ABOUT LUMATEPERONE
Lumateperone is an investigational treatment for adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate.21
While its exact mechanism of action is unknown, lumateperone is characterised by high serotonin 5-HT2A receptor occupancy and low amounts of dopamine D2 receptor occupancy at therapeutic doses.22
Lumateperone is approved by the U.S. Food and Drug Administration (FDA) to treat adults with schizophrenia and bipolar I or II disorder. A supplemental new drug application (sNDA) for lumateperone as an adjunctive treatment for adults with major depressive disorder is currently under U.S. FDA review.23,24
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.25 Seltorexant selectively antagonises the orexin-2 receptors, potentially improving mood symptoms and restoring sleep without next-day sedation in patients with depression.25,26 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.27,28 Seltorexant is the only investigational therapy being studied in MDD that is believed to work by normalising the overactivation of the orexin-2 receptors, thereby addressing the underlying biology that contributes to depression and causes insomnia symptoms.28
ABOUT SPRAVATO® (Esketamine nasal spray)
As an antagonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, esketamine nasal spray has a different mechanism of action and drug administration compared to other approved depression treatments.29,30
Esketamine nasal spray is self-administered, under the direct supervision of a healthcare professional, through a single-use nasal spray device, for the treatment of patients within the licensed indications. The decision to prescribe esketamine nasal spray should be determined by a psychiatrist.30
Esketamine nasal spray has been approved by the European Commission since 2019 and is indicated for:
- Use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI) in adult patients with TRD who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.30
- Co-administered use with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.30
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using esketamine nasal spray please refer to the Summary of Product Characteristics.
ABOUT SCHIZOPHRENIA
Schizophrenia is a complex, chronic brain disorder that affects how people think, feel, speak, and act. It affects approximately 23 million people worldwide yet remains widely misunderstood and insufficiently treated.31,32 Symptoms vary by person, but confusion and distortions in perceptions, emotions, and behaviour are common.32 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.33 A comprehensive treatment plan, which may include medication, therapy, and psychosocial services, can be critical in delaying the time to relapse for adults with schizophrenia.34,35
ABOUT JOHNSON & JOHNSON’S SCHIZOPHRENIA PORTFOLIO
Johnson & Johnson’s portfolio of schizophrenia therapies offers the broadest range of oral and long-acting injectable treatment options to support each patient’s individual treatment journey. The Company’s long-acting injectable treatments for adults with schizophrenia provides the most varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available, including INVEGA®, TREVICTA®, XEPLION®, and BYANNLI®.36,37,38,39,40
INVEGA® (paliperidone), is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older and for the treatment of schizoaffective disorder in adults. For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using paliperidone (prolonged-release suspension for injection) please refer to the Summary of Product Characteristics.36
BYANNLI® (paliperidone), a 6-monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly or 3-monthly paliperidone palmitate injectable products. For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using paliperidone (prolonged release suspension for injection) please refer to the Summary of Product Characteristics.37
TREVICTA® (paliperidone), a 3-monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate injectable product. For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using paliperidone (prolonged-release suspension for injection) please refer to the Summary of Product Characteristics.38
XEPLION® (paliperidone), is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using paliperidone (prolonged-release suspension for injection) please refer to the Summary of Product Characteristics.39
Lumateperone is a once-daily oral therapy approved by the U.S. FDA to treat adults with schizophrenia. A supplemental New Drug Application (sNDA) for lumateperone with long-term data evaluating the safety and efficacy of the medication for the prevention of relapse in schizophrenia was recently submitted to the U.S. FDA.40
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 www.innovativemedicine.jnj.com/emea/.
Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea/
Janssen-Cilag International NV is a Johnson & Johnson company.
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 Lumateperone, Seltorexant, SPRAVATO®, BYANNLI®, TREVICTA®, XEPLION® and INVEGA®. 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 behaviour and spending patterns of purchasers of healthcare products and services; changes to applicable laws and regulations, including global healthcare reforms; and trends toward healthcare 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 U.S. 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.
© Johnson & Johnson 2025. All rights reserved.
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CP-546093
October 2025
1 Clayton A, Earley W.R., Kozauer S.G, et al. Evaluation of Sexual Function With Adjunctive Lumateperone in Patients With Major Depressive Disorder. ECNP 2025, October 11-14, 2025. Presentation PS04-3102.
2 Flossbach Y, Mesens S, Xia L, et al. Developments in Adjunctive Treatment: Seltorexant Versus Quetiapine in Managing Major Depressive Disorder With Insomnia Symptoms. ECNP 2025; October 11-14, 2025. Oral Presentation.
3 Oliveira-Maia AJ, Baune BT, Bartova L, et al. Patient Characteristics Associated With Relative Benefit of Esketamine Nasal Spray Versus Quetiapine Extended Release on Achieving Remission in ESCAPE-TRD Study. ECNP 2025; October 11-14, 2025. Poster PS02-1219.
4 Llorca PM, Sauvaget A, Olie E, et al. Evolution of Clinical Dimensions and Safety in Patients Treated by Esketamine: Results The French Real-World ELLIPSE Study. ECNP 2025; October 11-14, 2025. Presentation PS02-1111.
5 Young AH, Fagiolini A, Perry R, et al. Expert Consensus on Decision-Making Factors for Continuation of Esketamine Nasal Spray in Treatment-Resistant Depression: A Delphi Method. ECNP 2025; October 11-14, 2025. Poster PS04-3215.
6 World Health Organization. Depressive disorders (depression). Available at:
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https://www.ajmc.com/view/economic-burden-and-managed-care-considerations-for-the-treatment-of-insomnia. Last accessed: October 2025.
16 Ağargün MY, Kara H, Solmaz M. Sleep disturbances and suicidal behaviour in patients with major depression. J Clin Psychiatry. 1997;58(6):249-51.
17 McIntyre RS, et al. Treatment-resistant depression: definition, prevalence, detection, management, and investigational interventions. World Psychiatry. 2023; 22(3):394-412.
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19 Marwaha S, et al. Novel and emerging treatments for major depression. Lancet. 2023 Jan 14;401(10371):141-153.
20 Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17.
21 Titulaer J, et al. Lumateperone-mediated effects on prefrontal glutamatergic receptor-mediated neurotransmission: A dopamine D1 receptor dependent mechanism. Eur Neuropsychopharmacol. 2022 Sep;62:22-35.
22 Cooper D, Gupta V. Lumateperone. [Updated 2023 Jul 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK560844/
23 Intra-Cellular Therapies. Press Release: Intra-Cellular Therapies Submits Supplemental New Drug Application (sNDA) to FDA for CAPLYTA® (lumateperone) for the Treatment of Major Depressive Disorder as Adjunctive Therapy. Available at:
https://www.globenewswire.com/news-release/2024/12/03/2990492/30597/en/Intra-Cellular-Therapies-Submits-Supplemental-New-Drug-Application-sNDA-to-FDA-for-CAPLYTA-lumateperone-for-the-Treatment-of-Major-Depressive-Disorder-as-Adjunctive-Therapy.html. Last accessed: October 2025.
24 U.S. Food and Drug Administration. CAPLYTA Prescribing Information. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209500s009lbl.pdf. Last accessed: October 2025.
25 Recourt K, de Boer P, Zuiker R, et al. The selective orexin-2 antagonist seltorexant (JNJ-42847922/MIN-202) shows antidepressant and sleep-promoting effects in patients with major depressive disorder [published correction appears in Transl Psychiatry. 2019 Oct 2;9(1):240].
26 Meshkat S, et al. Efficacy of orexin antagonists for the management of major depressive disorder: A systematic review of randomized clinical trials, Journal of Affective Disorder. 2025; 372: 409-419.
27 Nollet M, Leman S. Role of orexin in the pathophysiology of depression: potential for pharmacological intervention. CNS Drugs. 2013;27(6):411-422.
28 Brooks S, Jacobs GE, de Boer P, et al. The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia. J Psychopharmacol. 2019;33(2):202-209.
29 Hillhouse T, et al. A brief history of the development of antidepressant drugs: from monoamines to glutamate. Exp Clin Psychopharmacol. 2015; 21:1–21.
30 European Medicines Agency (EMA). Summary of Product Characteristics: SPRAVATO. Available from:
https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf. Last accessed: October 2025.
31 World Health Organisation. Schizophrenia. Available at:
https://www.who.int/news-room/fact-sheets/detail/schizophrenia. Last accessed: October 2025.
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33 Birchwood, M. “Early intervention and sustaining the management of vulnerability.” The Australian and New Zealand Journal of Psychiatry. vol. 34 Suppl (2000): S181-4.
34 Hany M, et al. Schizophrenia. [Updated 2024 Feb 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK539864/.
35 Keepers A, et al. The American Psychiatric Association Practice Guideline for the Treatment of Patients With Schizophrenia. Am J Psychiatry. 2020; 177 (9): 868 -872
36 European Medicines Agency (EMA). Summary of Product Characteristics: INVEGA. Available from:
https://www.ema.europa.eu/en/documents/product-information/invega-epar-product-information_en.pdf. Last accessed: October 2025.
37 European Medicines Agency (EMA). Summary of Product Characteristics: BYANNLI. Available from:
https://www.ema.europa.eu/en/documents/product-information/byannli-epar-product-information_en.pdf. Last accessed: October 2025.
38 European Medicines Agency (EMA). Summary of Product Characteristics: TREVICTA. Available from:
https://www.ema.europa.eu/en/documents/product-information/trevicta-epar-product-information_en.pdf. Last accessed: October 2025.
39 European Medicines Agency (EMA). Summary of Product Characteristics: XEPLION. Available from:
https://www.ema.europa.eu/en/documents/product-information/xeplion-epar-product-information_en.pdf. Last accessed: October 2025
40 Johnson & Johnson. Press Release: Supplemental new drug application submitted to U.S. FDA for CAPLYTA® (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo. Available at:
https://www.jnj.com/media-center/press-releases/supplemental-new-drug-application-submitted-to-u-s-fda-for-caplyta-lumateperone-with-data-demonstrating-significant-schizophrenia-relapse-prevention-compared-to-placebo. Last accessed: October 2025.