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Andrea Fagiolini

24 papers in the library · 1,144 citations · publishing 2019-2026

Papers

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530. Detecting neuroplastic effects induced by ketamine and classic psychedelics in healthy human subjects

International Journal of Neuropsychopharmacology September 9, 2026 C Agnorelli, J Peill, D Kurtin et al.

Abstract Background Clinical studies have shown that ketamine and classic psychedelics can produce robust and rapid antidepressant effects after a single or a few administrations. However, the neurobiological mechanisms driving these long-lasting changes remain unclear. A leading framework proposes that both drug classes induce sustained increases in neuroplasticity, potentially reshaping...

Profiling intranasal esketamine for adults with major depressive disorder and acute suicidal ideation or behavior: a phenotype-informed drug profile

Expert Review of Neurotherapeutics August 18, 2026 Mario Pinzi, Alessandro Cuomo, Maria Beatrice Rescalli et al.

INTRODUCTION: Acute suicidal ideation in major depressive disorder (MDD) is a psychiatric emergency requiring rapid risk assessment, containment, and treatment. Conventional monoaminergic antidepressants have delayed onset, leaving an interval during which severe depressive distress persists. Intranasal esketamine, a rapid-acting N-methyl-D-aspartate receptor antagonist, is approved for MDD...

Faster and greater antidepressant response to intravenous ketamine in bipolar compared with unipolar treatment-resistant depression: Diagnostic and sex-related findings from a naturalistic study.

Psychiatry Research August 1, 2026 Pietro Carmellini, Andrea Fagiolini, Mario Pinzi et al.

Intravenous ketamine has emerged as a rapid-acting antidepressant intervention that has shown promising effects in patients with treatment-resistant depression, although evidence remains heterogeneous and less well established across diagnostic subtypes. Nevertheless, real-world data comparing diagnostic subtypes and sex-related differences remain limited. This observational study examined the...

Clinical guidance on the use of esketamine nasal spray for patients with treatment resistant depression: A European Delphi consensus report.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology July 17, 2026 Allan H. Young, Bernhard T Baune, Beatrice Benatti et al.

Esketamine nasal spray (NS) is an established treatment for patients with treatment resistant depression (TRD). To further optimise real-world outcomes, consensus is needed regarding strategies to enhance patient outcomes and decision-making factors for pivotal timepoints in esketamine NS treatment. This modified Delphi panel (3 rounds) established expert consensus (≥80% agreement) from 30...

The Monoamine-Glutamate Continuum of Depression: A Neurobiological Framework for Precision Psychiatry.

Pharmaceuticals (Basel, Switzerland) April 24, 2026 Pietro Carmellini, Alessandro Cuomo, Maria Beatrice Rescalli et al.

Background/Objectives: Major depressive disorder (MDD) remains a leading cause of disability worldwide and exhibits substantial biological heterogeneity that is not adequately captured by current symptom-based diagnostic systems. While the classical monoamine hypothesis has historically guided antidepressant development, it does not fully account for variability in treatment response, delayed...

Detecting neuroplastic effects induced by ketamine in healthy human subjects: A multimodal approach.

Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism March 21, 2026 Claudio Agnorelli, Joseph Peill, Gabriela Sawicka et al.

We investigated ketamine's neuroplastic effects in healthy human subjects using integrated Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI) measures before and 1-8 days after a single psychedelic dose of ketamine (1 mg/kg, intravenous). Eleven male participants underwent two PET/MRI scans with [11C]-UCBJ (synaptic density/plasticity), 1H-MRS (glutamate and GABA) and...

Advances in antidepressant pharmacotherapy: phase 3 evidence and clinical perspectives.

Expert Opinion on Pharmacotherapy February 1, 2026 Alessandro Cuomo, Mario Pinzi, Andrea Fagiolini

Major depressive disorder (MDD) remains a leading global cause of disability, with substantial clinical and societal burden. Despite the wide availability of antidepressants, many patients experience inadequate response, partial remission, or treatment-resistant depression. Emerging pharmacological options beyond traditional monoaminergic agents have shown promise in phase 3 clinical trials,...

Intranasal esketamine in treatment-resistant depression: long-term dosing patterns and clinical outcomes in a 5-year observational study.

Therapeutic Advances in Psychopharmacology 2026 Alessandro Cuomo, Roger S McIntyre, Despoina Koukouna et al. 1 citation

Treatment-resistant depression (TRD) remains a major clinical challenge, and long-term real-world data on intranasal esketamine are limited. To describe long-term dosing patterns and clinical outcomes associated with intranasal esketamine in routine clinical practice. Single-center observational cohort study with descriptive analyses. We analyzed 45 patients with TRD treated with intranasal...

Symptom modulation and tolerability of intravenous ketamine in treatment-resistant bipolar depression: A retrospective study.

Journal of Affective Disorders May 1, 2025 Alessandro Cuomo, Simone Pardossi, Giovanni Barillà et al. 7 citations

Ketamine's use in treating bipolar depression must account for risks, such as switching to manic episodes or worsening symptoms. This study examines ketamine's impact on depressive symptoms, focusing on 'inner tension,' 'sleep reduction,' and 'suicidal ideation' over four weeks in treatment-resistant bipolar disorder (TR-BD) patients. Fifty-nine patients with TR-BD were treated consecutively...

Efficacy of esketamine nasal spray over quetiapine extended release over the short and long term: sensitivity analyses of ESCAPE-TRD, a randomised phase IIIb clinical trial.

The British journal of psychiatry : the journal of mental science February 1, 2025 Allan H. Young, Pierre-Michel Llorca, Andrea Fagiolini et al. 7 citations

In patients with treatment resistant depression (TRD), the ESCAPE-TRD study showed esketamine nasal spray was superior to quetiapine extended release. To determine the robustness of the ESCAPE-TRD results and confirm the superiority of esketamine nasal spray over quetiapine extended release. ESCAPE-TRD was a randomised, open-label, rater-blinded, active-controlled phase IIIb trial. Patients had...

Neurophysiological correlates of ketamine-induced dissociative state in bipolar disorder: insights from real-world clinical settings.

Molecular Psychiatry January 14, 2025 Claudio Agnorelli, Alessandra Cinti, Giovanni Barillà et al. 8 citations

Ketamine, a dissociative compound, shows promise in treating mood disorders, including treatment-resistant depression (TRD) and bipolar disorder (BD). Despite its therapeutic potential, the neurophysiological mechanisms underlying ketamine's effects are not fully understood. This study explored acute neurophysiological changes induced by subanesthetic doses of ketamine in BD patients with...

Variations in BDNF and Their Role in the Neurotrophic Antidepressant Mechanisms of Ketamine and Esketamine: A Review.

International Journal of Molecular Sciences December 5, 2024 Simone Pardossi, Andrea Fagiolini, Alessandro Cuomo 43 citations

Brain-derived neurotrophic factor (BDNF) is critical for neuroplasticity, synaptic transmission, and neuronal survival. Studies have implicated it in the pathophysiology of depression, as its expression is significantly reduced in brain areas such as the prefrontal cortex and hippocampus in patients with depression. Our narrative review focuses on the relationship between BDNF, ketamine, and...

Neuroplasticity and Psychedelics: a comprehensive examination of classic and non-classic compounds in pre and clinical models

arXiv Preprint Archive November 29, 2024 Claudio Agnorelli, Meg J. Spriggs, Kate Godfrey et al. 32 citations

Neuroplasticity, the ability of the nervous system to adapt throughout an organism's lifespan, offers potential as both a biomarker and treatment target for neuropsychiatric conditions. Psychedelics, a burgeoning category of drugs, are increasingly prominent in psychiatric research, prompting inquiries into their mechanisms of action. Distinguishing themselves from traditional medications,...

Safety and tolerability of esketamine nasal spray versus quetiapine extended release in patients with treatment resistant depression.

European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology August 1, 2024 Roger S McIntyre, Istvan Bitter, Jozefien Buyze et al. 30 citations

In ESCAPE-TRD (NCT04338321), esketamine nasal spray (NS) significantly increased the probability of remission at Week 8, and of being relapse-free through Week 32 after remission at Week 8, versus quetiapine extended release (XR) in patients with treatment resistant depression (TRD). Here, we explore the time course, burden and consequences of treatment emergent adverse events (TEAEs) in the...

A Systematic Review on Ketamine and Esketamine for Treatment-Resistant Depression and Suicidality in Adolescents: A New Hope?

Children (Basel, Switzerland) June 29, 2024 Simone Pardossi, Andrea Fagiolini, Simona Scheggi et al. 12 citations

Treating depression in adolescents is a significant challenge, and major depressive disorder (MDD) with suicidal ideation and treatment-resistant depression (TRD) are common and potentially devastating to optimal psychological and physical development in this age group. Suicide is among the leading causes of youth mortality, and TRD occurs in up to 40% of adolescents with MDD. TRD involves...

Membrane Permeation of Psychedelic Tryptamines by Dynamic Simulations.

Biochemistry February 7, 2024 Vito F. Palmisano, Claudio Agnorelli, Andrea Fagiolini et al. 5 citations

High Resolution Image Download MS PowerPoint Slide Renewed scientific interest in psychedelic compounds represents one of the most promising avenues for addressing the current burden of mental health disorders. Classic psychedelics are a group of compounds that exhibit structural similarities to the naturally occurring neurotransmitter serotonin (5-HT). Acting on the 5-HT type 2A receptors (HT...

Efficacy and safety of ketamine and esketamine for unipolar and bipolar depression: an overview of systematic reviews with meta-analysis

Frontiers in Psychiatry February 1, 2024 Alessandro Rodolico, Pierfelice Cutrufelli, Antonio Di Francesco et al. 28 citations

Background Unipolar and bipolar depression present treatment challenges, with patients sometimes showing limited or no response to standard medications. Ketamine and its enantiomer, esketamine, offer promising alternative treatments that can quickly relieve suicidal thoughts. This Overview of Reviews (OoR) analyzed and synthesized systematic reviews (SRs) with meta-analysis on randomized...

Nationwide consensus on the clinical management of treatment-resistant depression in Italy: a Delphi panel

Annals of General Psychiatry November 26, 2023 Giuseppe Maina, Marina Adami, Giuseppe Ascione et al. 56 citations

Abstract Background Treatment-resistant depression (TRD) is defined by the European Medicines Agency as a lack of clinically meaningful improvement after treatment, with at least two different antidepressants. Individual, familiar, and socio-economic burden of TRD is huge. Given the lack of clear guidelines, the large variability of TRD approaches across different countries and the availability...

Characterization of the Binding Poses of Classical and Photoswitchable Psychedelics Interacting with 5-HT2AR

ChemRxiv February 7, 2023 Vito F. Palmisano, Claudio Agnorelli, David Erritzøe et al. 1 citation

Classic psychedelics are compounds that target the 5-hydroxytryptamine receptor type 2A (5-HT2AR), inducing profound changes in consciousness. Although these compounds most closely resemble the natural neurotransmitter serotonin, their therapeutic and psychoactive action is still not well understood. Therefore, a quantitative atomistic description of their interaction in the 5-HT2AR receptor is...

Practical recommendations for the management of treatment-resistant depression with esketamine nasal spray therapy: Basic science, evidence-based knowledge and expert guidance

The World Journal of Biological Psychiatry November 3, 2020 Siegfried Kasper, Wiesław Jerzy Cubała, Andrea Fagiolini et al. 84 citations

OBJECTIVES: -methyl-d-aspartate (NMDA) glutamate receptor antagonist, is a novel, fast-acting option in this patient population. This manuscript provides expert guidance on the practicalities of using esketamine nasal spray. METHODS: A group of six European experts in major depressive disorder (MDD) and TRD, with clinical experience of treating patients with esketamine nasal spray, first...

The effectiveness of ketamine on anxiety, irritability, and agitation: Implications for treating mixed features in adults with major depressive or bipolar disorder

Bipolar Disorders May 14, 2020 Roger S McIntyre, Orly Lipsitz, Nelson B Rodrigues et al. 64 citations

Abstract Objective To determine the effectiveness of intravenous (IV) ketamine on anxiety, irritability, agitation, and suicidality, in adults with treatment‐resistant major depressive disorder (MDD) or bipolar disorder (BD). Method Adults (N = 201) with treatment‐resistant MDD or BD received repeat‐dose IV ketamine treatment at a community‐based clinic. Mixed features were measured using...

Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression

JAMA Psychiatry June 5, 2019 Ella Daly, Madhukar H. Trivedi, Adam Janik et al. 766 citations

Importance: Controlled studies have shown short-term efficacy of esketamine for treatment-resistant depression (TRD), but long-term effects remain to be established. Objective: To assess the efficacy of esketamine nasal spray plus an oral antidepressant compared with an oral antidepressant plus placebo nasal spray in delaying relapse of depressive symptoms in patients with TRD in stable...

Membrane Permeation of Psychedelic Compounds

ChemRxiv Vito Federico Palmisano, Claudio Agnorelli, Andrea Fagiolini et al.

Renewed scientific interest in psychedelic compounds represents one of the most promising avenues for addressing the current burden of mental health disorders. Classic psychedelics are a group of compounds that exhibit structural similarities to the naturally occurring neurotransmitter serotonin (5-HT). Acting on the 5-HT type 2A receptors (5-HT2AR), psychedelics induce enduring...