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Massimo Clerici

11 papers in the library · 291 citations · publishing 2023-2026

Papers

Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression

Bipolar Disorders January 13, 2023 Giovanni Martinotti, Bernardo Dell’osso, Giorgio Di Lorenzo et al. 72 citations

Esketamine nasal spray reduced depressive symptoms in people with treatment-resistant bipolar depression as effectively as in those with unipolar treatment-resistant depression, with no significant differences in response or remission rates after one and three months. The treatment also showed greater anxiety-reducing effects in the bipolar group. No treatment-emergent affective switch occurred, supporting the safety and tolerability of esketamine for bipolar treatment-resistant depression.

Predicting outcome with Intranasal Esketamine treatment: A machine-learning, three-month study in Treatment-Resistant Depression (ESK-LEARNING)

Psychiatry Research July 29, 2023 Mauro Pettorruso, Roberto Guidotti, Giacomo D’andrea et al. 56 citations

Machine learning models predicted which patients with treatment-resistant depression would respond to esketamine nasal spray. In a retrospective study of 149 patients, three random forest classifiers achieved 68.53% accuracy for response at one month and 66.26% at three months, and 68.60% accuracy for remission at three months. Features such as severe anhedonia, anxious distress, mixed symptoms, and bipolarity positively predicted response and remission, while benzodiazepine use and depression severity were linked to delayed responses. The findings suggest machine learning may aid personalized treatment decisions for treatment-resistant depression.

Esketamine in treatment-resistant depression patients comorbid with substance-use disorder: A viewpoint on its safety and effectiveness in a subsample of patients from the REAL-ESK study

European Neuropsychopharmacology May 4, 2023 Stefania Chiappini, Giacomo D’andrea, Sergio De Filippis et al. 48 citations

Esketamine nasal spray reduces depression symptoms in patients with treatment-resistant depression who also have a substance use disorder. In 26 patients followed for three months, Montgomery-Asberg depression rating scale scores decreased significantly from baseline to one month and from one to three months. Side effects occurred in 73% of patients, most commonly dissociative symptoms and sedation, but none led to lasting harm and no abuse or misuse of the medication was reported. The findings suggest esketamine is effective and safe in this population, though the study is limited by its small sample and short follow-up.

Investigating the Effectiveness and Tolerability of Intranasal Esketamine Among Older Adults With Treatment-Resistant Depression (TRD): A Post-hoc Analysis from the REAL-ESK Study Group

American Journal of Geriatric Psychiatry July 8, 2023 Giacomo D’andrea, Stefania Chiappini, Roger S. McIntyre et al. 36 citations

Esketamine nasal spray (ESK-NS) shows preliminary effectiveness for treatment-resistant depression in adults aged 65 and older, with 53.3% of participants responding (MADRS score reduced by at least 50%) and 33.33% achieving remission (MADRS below 10) after three months. Common adverse effects included dizziness (50%), dissociation (33.3%), sedation (30%), and hypertension (13.33%). Twenty percent of participants discontinued treatment. These findings, from a post-hoc analysis of 30 older adults, suggest ESK-NS can be effective but is associated with high rates of treatment-emergent adverse events, most of which did not require stopping treatment.

Esketamine Treatment Trajectory of Patients with Treatment-Resistant Depression in the Mid and Long-Term Run: Data from REAL-ESK Study Group.

Current neuropharmacology January 1, 2025 Gianluca Rosso, Giacomo d'Andrea, Stefano Barlati et al. 23 citations

Among patients with treatment-resistant depression who continued esketamine nasal spray for at least six months, 76.2% responded or achieved remission. Of those who had not responded by six months, a subset improved by twelve months. Side effects occurred in 71.8% of patients at six months, decreasing to 42% at twelve months; the most common were sedation and dissociation. Only two patients stopped treatment due to tolerability issues. The findings suggest esketamine is effective and safe for mid- to long-term treatment, with a novel observation of late clinical response in some patients. Results require confirmation in larger samples and longer observation periods.

Patient Experience with Intranasal Esketamine in Treatment-Resistant Depression: Insights from a Multicentric Italian Study (REAL-ESKperience)

Journal of Personalized Medicine April 1, 2025 Marco Di, M. Pepe, G. D’andrea et al. 18 citations

Most patients with treatment-resistant depression reported positive experiences with esketamine nasal spray. In a survey of 236 outpatients, 88.4% reported enhanced quality of life. Satisfaction levels varied: 10.2% were unsatisfied, 19.1% partially satisfied, 44.4% satisfied, and 26.3% very satisfied. The most satisfied patients noted early improvements in depressed mood, suicidal thoughts, and restlessness, and reported functional gains across all domains. Artificial intelligence analysis of open-ended responses identified themes of personal growth and a desire for tailored treatment settings. Integrating patient-reported experiences may help personalize care and improve adherence.

Effectiveness of repeated Esketamine nasal spray administration on anhedonic symptoms in treatment-resistant bipolar and unipolar depression: A secondary analysis from the REAL-ESK study group.

Psychiatry Research July 26, 2025 G. D’andrea, C. Cavallotto, M. Pettorruso et al. 16 citations

Anhedonia, the reduced ability to experience pleasure, is a core symptom of both unipolar and bipolar depression that often responds poorly to standard antidepressants. In a real-world observational study of 253 treatment-resistant patients (199 with unipolar depression, 54 with bipolar depression), repeated doses of esketamine nasal spray added to ongoing medication significantly reduced anhedonia over three months. The effect was distinct from overall mood improvement. At three months, 51.92% of bipolar and 38% of unipolar patients showed at least a 50% reduction in anhedonia scores. Dropout rates were low (around 13–14%), and manic switches were rare. The findings suggest esketamine has a targeted, transdiagnostic anti-anhedonic effect.

Mentalization and Emotional-Cognitive Rigidity as predictors of esketamine's effects on Treatment-Resistant Depression: Findings from a prospective observational study.

Journal of Affective Disorders September 1, 2025 M. Olivola, Filippo Mazzoni, Barbara Tarantino et al. 8 citations

A six-month observational study of 36 patients with treatment-resistant depression found that those with poor mentalization abilities at the start had more severe depressive symptoms throughout treatment with esketamine. Greater cognitive rigidity appeared protective, possibly by stabilizing emotions and reducing negative thinking. The findings suggest esketamine may help break cognitive inflexibility and improve mentalization, supporting a personalized approach to treatment-resistant depression.

Personalizing esketamine treatment in TRD and TRBD: the role of mentalization, cognitive rigidity, psychache, and suicidality.

Frontiers in psychiatry January 1, 2025 Miriam Olivola, Filippo Mazzoni, Barbara Tarantino et al. 7 citations

In treatment-resistant depression, esketamine—a glutamatergic modulator approved in 2019—may improve not only depressive symptoms but also key psychological factors such as mentalization, psychache, social cognition, suicidality, and cognitive-emotional rigidity. In a six-month observational study of 36 patients with treatment-resistant depressive episodes, depressive symptoms significantly decreased, as measured by the Montgomery-Åsberg Depression Rating Scale. By six months, 69% of patients achieved remission, indicating a robust and sustained response. The findings suggest esketamine may be particularly beneficial in reducing cognitive rigidity and improving mentalization, potentially breaking the inflexible thinking patterns that sustain depression. Personalized treatment approaches are emphasized.

Effectiveness of Yoga as a Complementary Therapy for Anorexia Nervosa: A Systematic Review.

International journal of yoga January 1, 2024 Massimiliano Buoli, Francesca Legnani, Monic Mastroianni et al. 7 citations

Yoga appears to improve anorexia nervosa symptoms, particularly emotional dysregulation, but evidence is weak. A review of five studies found that all but one had serious methodological problems, including confounding factors like psychiatric comorbidity and small sample sizes. The authors conclude yoga is a candidate complementary treatment but call for more randomized controlled trials with larger samples and less bias to draw robust conclusions. They also suggest comparing yoga's effectiveness against psychotherapy or medication and adapting yoga practices to the specific needs of these patients.

Pilot study on esketamine response in treatment-resistant depression: impact of pharmacogenetic, clinical, and demographic variables.

Frontiers in pharmacology January 1, 2026 Michaela Krivosova, Matteo Marcatili, Gessica Guerrera et al.

In a real-world group of 32 patients with treatment-resistant depression receiving intranasal esketamine over two months, no single demographic, clinical, or genetic variable—including BDNF (rs6265), OPRM1 (rs1799971) polymorphisms, or CYP2B6, CYP2C9, and CYP3A4 metabolizer status—reliably predicted treatment response. Adjunctive psychotherapy was the only factor significantly associated with remission. Most patients received the standard 84 mg dose, so nominal dosing explained little of the outcome variability. Exploratory analyses suggested that metabolic phenotype and concomitant pharmacotherapy may contribute to inter-individual differences. The findings support a multidimensional, clinically oriented approach to optimizing esketamine treatment rather than relying on a single predictor. The small sample size may have limited the ability to detect modest associations, so results are exploratory.