Trintellix (vortioxetine) / Lundbeck, Takeda - LARVOL DELTA

Vortioxetine mitigates methotrexate-induced oral mucosa injury via sirtuin 1 pathway and intrinsic apoptosis signaling. (PubMed, BMC Oral Health) - No abstract available

Journal • Mucositis • Stomatitis

Vortioxetine in Subgroups of Patients with Major Depressive Disorder and Early-Stage Dementia: Further Results from the MEMORY Study. (PubMed, Neuropsychiatr Dis Treat) - P4 | "Our findings provide further support for the effectiveness and tolerability of vortioxetine in patients with MDD and early-stage dementia. Clinically significant improvement in depressive symptoms, cognitive performance, and health-related quality of life during treatment with vortioxetine was observed in patients with Alzheimer's disease, those with mixed-type dementia, patients receiving concomitant treatment with drugs for dementia, and those with severe depression."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Changes in functional connectivity of the default mode network and thalamus may be a therapeutic mechanism for the treatment of major depressive disorder with vortioxetine. (PubMed, Psychiatry Res Neuroimaging) - "Baseline analysis revealed a significant reduction in the fractional amplitude of low-frequency fluctuations (fALFF) in the bilateral posterior cingulate cortex (bPCC) of MDD patients compared to HCs. No significant correlations were observed between the functional metrics of these brain regions and clinical data (p > 0.05). Our results support the involvement of default mode network (DMN) dysfunction in MDD and propose that vortioxetine may alleviate depressive symptoms by modulating the DMN and thalamus."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Clinical trial to study the effect of an already authorized drug on othernpathologies by administering it to people with a recent diagnosis ofnschizophrenia. (clinicaltrialsregister.eu) - P2/3 | N=37 | Recruiting | Sponsor: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

Vortioxetine for Major Depressive Disorder with Chronic Pain: Clinical Evidence and Mechanistic Basis for a Multimodal Pharmacotherapeutic Approach. (PubMed, J Pain Palliat Care Pharmacother) - No abstract available

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry

Effectiveness and Tolerability of Vortioxetine in Major Depressive Disorder: A Real-World Study in Switzerland. (PubMed, Clin Drug Investig) - "Patients who initiated vortioxetine for treating a major depressive episode experienced improvements in depressive symptoms and functioning. Vortioxetine was well tolerated. Underestimation of depressive episode severity by clinicians reinforces the importance of using rating scales in clinical practice."

Journal • Real-world evidence • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

POST-MARKETING SAFETY PROFILE OF ANTIDEPRESSANTS IN 2013 TO 2025 (ISPOR 2026) - "Findings show numerous serious AE's associated with duloxetine, milnacipran, ketamine, and venlafaxine, which can lead to other serious outcomes, including hospitalization. It is necessary to continue and systematically monitor the safety associated with antidepressants and other associated medications."

Clinical • P4 data • CNS Disorders • Insomnia • Mood Disorders • Sleep Disorder

Vortioxetine Improves Cognition and Quality of Life in Racially and Ethnically Minoritized Individuals With Post-COVID-19 Condition: A Randomized, Double-blind, Placebo-controlled Trial (AAN 2026) - "Vortioxetine improved HRQoL in PCC and reduced racial disparities, providing the first evidence for an equity-focused, mechanism-informed therapeutic strategy, with the greatest benefit observed among cognitively intact participants from racially and ethnically marginalised groups."

Clinical • HEOR • Cognitive Disorders • Infectious Disease • Novel Coronavirus Disease

BDNF and Beyond: Unlocking the Therapeutic Potential of Neurotrophic Pathways in Depression (AAN 2026) - "Multimodal agents (e.g., vortioxetine) augmented glutamatergic transmission, LTP, and dendritic spine maturation; MAOIs elevated BDNF/IGF-1 and supported LTP. Rapid-acting NMDA antagonists (ketamine/esketamine) produced swift, durable antidepressant effects with increases in AMPA throughput, p-TrkB/c-CREB, and spine formation. Some drug classes showed heterogeneity (e.g., duloxetine/milnacipran with region-specific or inconsistent plasticity effects; sertraline with mixed LTP findings)... Neuroplasticity dysfunction is a core substrate of MDD, and therapeutic benefit tracks with restoration of plasticity—particularly via BDNF/IGF-1/NGF pathways. Targeting neurotrophic signaling (e.g., BDNF mimetics, IGF-1 analogs), pairing plasticity enhancers with standard antidepressants, and integrating neuromodulation may yield more durable remission and reduced relapse. Future work should standardize plasticity biomarkers (imaging, serum/csf neurotrophins) to stratify patients and..."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • BDNF • IGF1

Sequenced treatment alternatives to relieve adolescent depression: A pragmatic clinical trial. (PubMed, J Affect Disord) - "In this study, fluoxetine combined with CBT showed no significant advantage over fluoxetine monotherapy. All strategies in step 2 were feasible and acceptable. Our findings supported the feasibility of th sequential treatment pathway for adolescent MDD and provided insights for future adequately powered trials."

Journal • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Response to immune-based augmentation treatment for depression: a potential role of immunosenescence. (PubMed, Neurosci Appl) - "All patients were treated with vortioxetine and randomized to receive either celecoxib (N = 55) or placebo (N = 58) by a randomized design. Our result fits with the growing body of literature focusing on immunosenescence and that aging of the immune system is relevant for treatment response and personalized treatment choices. Replication in an independent sample is needed to confirm the role of age in immune-focused treatment strategies for depression."

Journal • CNS Disorders • Depression • Inflammation • Major Depressive Disorder • Mood Disorders • Psychiatry • CD4 • CD8 • CRP

Depressive Symptoms, Functional Status, and Cardiovascular Parameters in Patients with Major Depressive Disorder Undergoing Cardiac Rehabilitation While Treated with Vortioxetine: A Prospective Observational Study. (PubMed, J Clin Med) - " In patients with MDD and undergoing CR while receiving vortioxetine, longitudinal changes were observed in psychological, functional, and selected cardiovascular measures. These real-world data describe clinical trajectories within integrated rehabilitation settings and provide hypothesis-generating evidence for future controlled studies."

Journal • Observational data • Cardiovascular • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Emotional Blunting in Hong Kong Patients with Major Depressive Disorder Treated with Vortioxetine: A Naturalistic Observational Study. (PubMed, Biomedicines) - " In this naturalistic observational cohort of patients with MDD who were prescribed vortioxetine, self-reported emotional blunting, depressive symptoms, cognitive dysfunction, functional impairment, and fatigue decreased over eight weeks. Anhedonia scores (SHAPS) decreased to non-significant levels, and clinician-rated Clinical Global Impression scores confirmed a significant reduction in illness severity."

Journal • Observational data • CNS Disorders • Cognitive Disorders • Depression • Fatigue • Major Depressive Disorder • Mood Disorders • Psychiatry

RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE) (clinicaltrials.gov) - P4 | N=120 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Development of long-acting intramuscular vortioxetine pamoate suspensions: Formulation optimization and pharmacokinetic evaluation. (PubMed, Eur J Pharm Biopharm) - "Additionally, lower burst releases were confirmed (rat 10.2%, dog 3.8%) by the animal test. This study confirms that the VTXP suspension achieves long-acting performance and low burst release for IM administration."

Journal • PK/PD data

Vortioxetine: A comprehensive profile. (PubMed, Profiles Drug Subst Excip Relat Methodol) - "VX possesses a multimodal mechanism of action that includes inhibition of serotonin transporter (SERT) and direct modulation of serotonin receptors (i.e., 5-HT1A, 5-HT1B, 5-HT3, 5-HT1D, and 5-HT7). This monograph presents a comprehensive review that includes a description (i.e., taxonomy, nomenclature, impurities, etc.), different synthesis methods, physical characteristics (i.e., appearance, color, solubility, thermodynamic properties, etc.), methods of analysis (i.e., spectroscopic, chromatographic, electrochemical methods), stability and degradation, pharmacology (i.e., pharmacodynamics, pharmacokinetics), therapeutic uses, and adverse and toxic effects of VX."

Journal • Review • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Advances in antidepressant pharmacotherapy: phase 3 evidence and clinical perspectives. (PubMed, Expert Opin Pharmacother) - "Data on efficacy, safety, and relapse prevention from pivotal trials of brexanolone, intranasal esketamine, dextromethorphan - bupropion, vortioxetine, and metabolism-based interventions such as glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are discussed. However, limited guideline integration, insufficient long-term data, and implementation barriers restrict their clinical uptake. Clearer sequencing strategies and harmonized recommendations are needed to support more individualized depression management."

Journal • P3 data • Review • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Postpartum Depression • Psychiatry • Suicidal Ideation

Successful bioequivalence prediction of immediate-release vortioxetine tablets through prospective virtual crossover and parallel trials. (PubMed, J Pharm Sci) - "The selected formulation was bioequivalent with the reference product (90% CI: 97.77-106.05% for Cmax and 96.52-104.32% for AUC0-72h, n = 36). Proposed workflow provides a realistic approximation of bioequivalence study outcome."

Journal

Comparative effect of vortioxetine and sertraline on clinical and inflammatory profile in Parkinson's disease with comorbid depression. (PubMed, Front Neurosci) - "Both drugs display an antidepressant activity, but vortioxetine was superior to sertraline in improving cognitive function, anxiety, anhedonia, and apathy. These data evaluate for the first time the immunomodulatory effects of two different treatments in PD patients with comorbid depression, highlighting the greater immunomodulatory capacity of vortioxetine."

IO biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Inflammation • Major Depressive Disorder • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • CD40 • ICAM1

Lundbeck reports Q4 results with mixed performance, issues 2026 outlook (Investing.com) - "The company’s key products Vyepti, Abilify franchise, and Trintellix performed ahead of expectations, while Rexulti missed consensus estimates by 9%. Lower gross margins were more than offset by reduced SG&A spending, contributing to the EBITDA beat...While the company appears on track to meet its mid-term targets through 2027, it faces revenue challenges beyond that period as key products Abilify Maintena and Trintellix/Brintellix face generic pressure starting in 2026."

Commercial • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • Depression • Migraine • Pain • Schizophrenia

Neural - adipose crosstalk: Shared genetic architecture of visceral fat and neuropsychiatric disorders. (PubMed, J Adv Res) - "These findings support a shared genetic framework for brain-adipose crosstalk centered on hypothalamic-synaptic mechanisms and highlight potential therapeutic targets for comorbid management."

Journal • CNS Disorders • Genetic Disorders • Mental Retardation • Metabolic Disorders • Obesity • Psychiatry

Antidepressant Use and Risk of Reoperation After Distal Radius Open Reduction and Internal Fixation: A Propensity Score-Matched Cohort Study. (PubMed, J Hand Surg Glob Online) - "Two mutually exclusive exposure comparisons were analyzed: SSRI users versus nonusers and non-SSRI serotonergic users (serotonin-norepinephrine reuptake inhibitors), tricyclic antidepressants, serotonergic monoamine oxidase inhibitors, vortioxetine, or vilazodone versus nonusers, defined by ≥2 prescriptions in the 180 days preindex. Preoperative antidepressant exposure to SSRIs or non-SSRI serotonergic agents was associated with a small but clinically relevant increase in unplanned reoperation after distal radius ORIF. Prognostic III."

Journal • Musculoskeletal Diseases • Orthopedics

A Randomized, Double-Blind, Placebo-Controlled Study of Vortioxetine Combination with Adjuvant Chemotherapy (With or Without Radiotherapy) for Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery with Curative Intent (ChiCTR) - P4 | N=280 | Not yet recruiting | Sponsor: The international peace maternity and child health hospital; The international peace maternity and child health hospital | Initiation date: Oct 2025 ➔ Feb 2026

Trial initiation date • Endometrial Cancer • Oncology • Solid Tumor

Management strategies for burning mouth syndrome: a comprehensive review. (PubMed, J Oral Facial Pain Headache) - "Key pharmacological treatments such as clonazepam and capsaicin are explored in detail, alongside the potential of newer agents like various classes of antidepressants (including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin and noradrenaline reuptake inhibitors, vortioxetine) and antiepileptics showing promise in addressing the multifactorial nature of BMS. The integration of telemedicine and digital health resources is proposed to enhance patient management and accessibility to multidisciplinary care. This review provides a comprehensive update on all available therapeutic approaches for BMS, encompassing pharmacological treatments, non-pharmacotherapeutic interventions, and lifestyle optimization strategies, offering a holistic perspective on managing this condition."

Journal • Review • Pain

Prediction of 12-Week Remission in Patients With Depressive Disorder Using Reasoning-Based Large Language Models: Model Development and Validation Study. (PubMed, JMIR Ment Health) - "We analyzed data from 390 patients in the MAKE Biomarker discovery study who were undergoing first-step antidepressant monotherapy with 12 different medications, including escitalopram, paroxetine, sertraline, duloxetine, venlafaxine, desvenlafaxine, milnacipran, mirtazapine, bupropion, vortioxetine, tianeptine, and trazodone, after excluding those with uncommon medications (n=9) or missing biomarker data (n=32). Clinical evaluation by psychiatrists showed favorable mean ratings for correctness (4.3, SD 0.7), consistency (4.2, SD 0.8), specificity (4.2, SD 0.7), helpfulness (4.2, SD 1.0), and human likeness (3.6, SD 1.7) on 5-point scales. These findings demonstrate that reasoning-based LLMs, particularly when enhanced with research-informed prompting, show promise for predicting antidepressant response and could serve as interpretable adjunctive tools in depressive disorder treatment planning, although prospective validation in real-world clinical settings remains..."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry