Invega Trinza (paliperidone palmitate extended-release 3-month injection) / J&J - LARVOL DELTA

A Bioequivalence Study of PP3M in Patients With Schizophrenia (clinicaltrials.gov) - P=N/A | N=260 | Recruiting | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New trial • CNS Disorders • Psychiatry • Schizophrenia

Case Series: Simultaneous Use of Long-Acting Injectable Antipsychotics and Vivitrol or Long-Acting Buprenorphine in Dual Diagnosis Patients with Bipolar Disorder and Substance Use Disorders. (PubMed, Psychopharmacol Bull) - "Medication combinations included paliperidone palmitate with Sublocade (n = 2) and aripiprazole lauroxil with Sublocade (n = 1). This combination approach may be particularly valuable for patients with poor medication adherence. Preliminary findings support the need for controlled research to establish optimal patient selection criteria, medication combinations, and predictors of treatment response."

Journal • Retrospective data • Addiction (Opioid and Alcohol) • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Clinical Practice Recommendations for Switching from Once-Monthly to Longer-Interval Paliperidone Palmitate Injectable in Schizophrenia Patients: A Modified Delphi Study in China. (PubMed, Neuropsychiatr Dis Treat) - "Switching from short-interval LAIs (such as paliperidone palmitate one-month formulation, PP1M) to longer-intervals LAIs (like paliperidone palmitate three-month and six-month formulations) offers additional benefits to disease outcome. Final consensus was reached on 33 statements across five domains: clinical necessity, target patient populations, switching strategy, long-term disease management, factors influencing treatment willingness. It presents the first expert consensus in China on longer-interval LAIs usage in schizophrenia, offering evidence-informed guidance for patient selection, switching strategies and long-term disease management to promote standardized clinical use."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

Impact of macrophages on the dissolution of LAI suspension prodrugs. (PubMed, Int J Pharm) - "In this study, we investigated the role of macrophages in the dissolution and metabolic conversion of two clinically approved LAI prodrugs aripiprazole lauroxil (Aristada®) and paliperidone palmitate (Invega Trinza®) and their qualitatively and quantitatively (Q1Q2) equivalent formulations...Together, these findings suggest that macrophages complement the particle-size-dependent dissolution process by further modulating the dissolution and metabolic handling of LAI suspension prodrugs. This work provides new mechanistic insight into macrophage-mediated drug disposition at the injection site and has important implications for the design and performance prediction of LAI formulations."

Journal

Healthcare resource savings from administering paliperidone palmitate once every 3 months instead of once every month for schizophrenia: a 12-month mirror-image analysis of real-world population-based data. (PubMed, Ther Adv Psychopharmacol) - "Inadequate adherence to antipsychotic medication remains a major driver of relapse, hospitalization, and chronic disease progression in schizophrenia. Transitioning from PP1M to PP3M for schizophrenia treatment can significantly reduce healthcare resource utilization and costs. Notably, hospitalization and emergency room visit costs were reduced by approximately half."

Journal • Real-world evidence • CNS Disorders • Psychiatry • Schizophrenia

A Multicentre, 4-Year Mirror-Image Study Comparing the Effectiveness of Long-Acting Injectable Antipsychotics in the Treatment of Bipolar Disorder: Results From the LAICO Study. (PubMed, Bipolar Disord) - "Study findings suggest that long-acting antipsychotics such as A1M, PP1M, and particularly PP3M are associated with high retention and lower hospitalisation rates after 2 years of treatment in patients with BD."

Clinical • Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry

Prolonged Tardive Dyskinesia Induced by Long-Acting Paliperidone Palmitate in Schizophrenia: A Case Report. (PubMed, Am J Case Rep) - "Dose reduction to 350 mg was ineffective; the long-acting injection was stopped in June 2019, and aripiprazole 10 mg/day was started. Adjuncts (trihexyphenidyl, amantadine, and intermittent benzodiazepines) provided only limited benefit...Over 6 years without vesicular monoamine transporter 2 (VMAT-2) inhibitors, her dystonia lessened but persisted, and she was discharged on clozapine and fluvoxamine...Given therapeutic limits, variable prognosis, and the 3-month formulation's extended pharmacokinetics, clinicians should maintain high suspicion, minimize dopamine-receptor-blocking exposure, and individualize care, considering timely VMAT-2 inhibitors or clozapine, plus structured long-term motor monitoring and shared decision-making. This report highlights the presentation of tardive dyskinesia as a complication of antipsychotic medication and the approach to management of this iatrogenic syndrome."

Journal • CNS Disorders • Dystonia • Movement Disorders • Psychiatry • Schizophrenia

Comparison of Side Effects Between 3-Monthly and 1-Monthly Paliperidone Palmitate Formulations in Patients With Schizophrenia. (PubMed, Hum Psychopharmacol) - "In this within-patient cohort stabilized on PP1M, conversion to PP3M was not associated with an increase in overall UKU side-effect burden. Selecting the appropriate dose before switching and preferring monotherapy may enhance treatment comfort. These results may help guide clinicians in selecting long-acting injectable antipsychotics in practice."

Adverse events • Clinical • Journal • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Psychiatry • Schizophrenia

12-Month mirror study on the effectiveness and safety of six-month paliperidone palmitate in patients with schizophrenia: A Multicenter Andalusian Cohort (PAPSEM study). (PubMed, Psychiatry Res) - "PP6M is an effective and well-tolerated option for patients with schizophrenia in real-world clinical practice. It reduces hospitalizations, improves clinical outcomes, and may contribute to decreased substance use."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Targeting the ApoB100-ENO1 Interaction with Engineered Peptides Attenuates Atherosclerotic Inflammation and Plaque Progression. (PubMed, Transl Res) - "The ApoB100-ENO1 axis is a critical driver of macrophage-mediated inflammation in atherosclerosis. The novel peptide PP3m effectively inhibits this interaction, reducing vascular inflammation and plaque progression without altering lipid levels. PP3m represents a promising therapeutic candidate for cardiovascular disease by targeting residual inflammatory risk through a lipid-independent mechanism."

Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • Inflammation • APOB • CD68 • CXCL8 • ENO1 • IL6

Cost-Minimization Analysis of Aripiprazole 2-Month Ready-to-Use vs. Other Long-Acting Injectable Antipsychotics: Evidence From Ontario (ISPOR-EU 2025) - "Pharmacokinetic bridging data demonstrates comparable exposure to aripiprazole once-monthly (AOM) with prolonged post dose protection.Objective: To evaluate the economic impact on the Ontario Drug Benefit (ODB) program of funding Ari 2MRTU by comparing annual treatment costs with existing reimbursed LAI antipsychotics for maintenance therapy in adults diagnosed with schizophrenia A cost-minimization model was developed from the ODB perspective over a 1-year time horizon, assuming therapeutic equivalence among comparators...Comparators (AOM, risperidone LAI, paliperidone palmitate once monthly [PP1M], and three-monthly [PP3M]) were evaluated per label dosing... These results demonstrate that Ari 2MRTU may deliver cost savings for maintenance treatment of schizophrenia when compared to other LAIs, and this was acrossdifferent initiation scenarios and care settings"

HEOR • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia

COST-CONSEQUENCES EVALUATION OF EXTRAPYRAMIDAL SYMPTOMS MANAGEMENT IN SCHIZOPHRENIA: REAL-WORLD COMPARISON OF ORAL ANTIPSYCHOTICS VS LONG-ACTING INJECTABLE ANTIPSYCHOTICS (LAIS) IN BOGOTÁ AND MEDELLÍN, COLOMBIA (WCN 2025) - "LAIs like PP3M demonstrate a superior safety profile, significantly reducing the incidence of EPS compared to oral antipsychotics. They are cost-effective, improving patient quality of life and optimizing healthcare resources. An interdisciplinary approach between psychiatry and neurology is recommended to enhance EPS management and improve clinical and socioeconomic outcomes."

Clinical • Real-world • Real-world evidence • CNS Disorders • Dystonia • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Probable seronegative autoimmune psychosis: a case highlighting the diagnostic value of CSF investigation (ECNP 2025) - "The patient's history revealed that she had been treated with paliperidone palmitate 100 mg/month, clozapine (425 mg/day), and valproic acid (1000 mg/day) without clinical improvement over three months. This case underscores the importance of recognizing autoimmune psychosis in psychiatric inpatients with subacute onset and treatment-refractory neurocognitive impairments. It highlights the need to incorporate cerebrospinal fluid analysis and functional neuroimaging into routine diagnostic evaluations in psychiatric settings. In cases where autoantibodies are not detectable, the presence of inflammatory CSF markers and functional imaging abnormalities should prompt early immunotherapeutic intervention, with the potential to prevent diagnostic delays and significantly improve patient outcomes."

Clinical • IO biomarker • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Mental Retardation • Psychiatry • Psychomotor Agitation

COVID-19-Related psychosis and 3-year follow-up: A case report (ECNP 2025) - "During hospitalization, she was treated with intramuscular haloperidol and biperiden, followed by paliperidone palmitate...Due to persistent anhedonia and lack of motivation, sertraline 50 mg/day was added, resulting in full remission...Despite experiencing recurrent episodes, the patient achieved full remission and significant functional recovery. Her complete symptom resolution and reintegration into academic life underscore the importance of future studies to better understand the psychiatric impacts of the pandemic."

Case report • Clinical • CNS Disorders • Mental Retardation • Psychiatry

Measurement of the Personal and Social Performance (PSP) Scale in patients treated with antipsychotics (ECNP 2025) - "Next in line were Ziprasidone (63.0), monthly Paliperidone (61.3), oral Olanzapine (60.9), total Paliperidone use (56.2), three-month Paliperidone (55.3), Risperidone (54.5), and six-month Paliperidone (50.7). At the lower end of our data, Clozapine showed the lowest PSP scores, with an average of 48.7 points... The results suggest that third-generation antipsychotics are associated with better functionality, as measured by the PSP Scale, compared to second-generation antipsychotics. This difference may reflect a more favorable profile of third-generation antipsychotics, with fewer sedative and metabolic side effects, which could contribute to improved quality of life and functioning in patients. It is also important to consider the individual response of patients and adherence to treatment.These findings reinforce our understanding of the superiority of partial agonists such as Aripiprazole and Cariprazine over dopamine antagonists in preserving and restoring patient..."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Risperidone ISM vs Paliperidone Palmitate on a sample of patients affected by schizophrenia: preliminary results from an observational comparative study (ECNP 2025) - "However, patient-reported results indicate some differences, which could depend on the intrinsic characteristics of the two drugs or on demographic or anamnestic differences of the patients. Further studies with larger sample, more homogeneous and comparable cohorts are needed to clarify the underlying reasons for these discrepancies in subjective outcome measures."

Clinical • CNS Disorders • Psychiatry • Schizophrenia • Substance Abuse • DRD2

Impact of paliperidone palmitate 1-month and 3-month long-acting injectable antipsychotics on clinical and psychosocial outcomes in Rwandan patients with schizophrenia (ECNP 2025) - P4 | "Results showed that switching from OAPs to paliperidone palmitate LAI led to statistically significant and clinically meaningful improvements in long-term symptomatic response, psychosocial functioning, patient and clinician satisfaction, and reduction in caregiver burden, in Rwandan patients with schizophrenia."

Clinical • CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

Paliperidone Palmitate every three months (PP3M) compared to PP1M in people with severe schizophrenia. Treatment outcomes and satisfaction (ECNP 2025) - "Therefore, PP3M formulation allows patients not only to improve treatment outcomes but also to feel more satisfied. Long-term naturalistic studies with larger sample sizes on specific real-world populations must confirm our results."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

TREATMENT EFFECTS OF LONG-ACTING INJECTABLE ANTIPSYCHOTICS ON NEGATIVE SYMPTOMS OF SCHIZOPHRENIA: A NETWORK INTERVENTION ANALYSIS (WPA-WCP 2025) - "Objectives This prospective cohort study compared the longitudinal trajectories of negative symptom improvement in schizophrenia between three monthly (PP3M) and once monthly (PP1M) paliperidone palmitate formulations, with particular focus on dynamic symptom-network interactions through novel network intervention analysis (NIA). The sex differences observed, with males benefiting more from PP3M, emphasize the need for personalized treatment. These findings provide mechanistic evidence to optimize injection intervals and advance precision psychopharmacology, offering critical insights for refining antipsychotic treatment strategies and improving outcomes in schizophrenia."

CNS Disorders • Psychiatry • Schizophrenia

Successful Transition From Covert, Involuntary Oral Medication to Consensual, Long-Acting, Injectable Antipsychotic Therapy in a Patient With Schizophrenia: A Case Report From Japan. (PubMed, Cureus) - "For three months, his aged father covertly administered oral risperidone...After engaging in shared decision-making focused on the patient's personal recovery goals, such as improving computer skills and living more independently, he consented to therapy with paliperidone palmitate LAI...LAI antipsychotics offer an effective and ethically sound alternative to covert medication in schizophrenia. This approach can strengthen the therapeutic alliance, enhance patient autonomy, and lead to meaningful improvements in clinical symptoms and real-world functioning, providing a valuable solution within challenging sociocultural contexts."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Aerobic Exercise Enhances the Impact of Cognitive Training on Positive Symptoms After a First Episode of Schizophrenia. (PubMed, Behav Modif) - "All participants were also randomly assigned to either oral risperidone or paliperidone palmitate (PP1M) in a concurrent antipsychotic medication study. The two medication groups did not significantly differ on either positive symptom outcome, and there were no three-way interactions. Our findings suggest that the enhancing effect of adding aerobic exercise to cognitive training extends beyond cognitive gains and includes positive psychotic symptoms."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Barriers to transitioning from monthly to 3-monthly paliperidone palmitate formulation: Patient characteristics and physician intentions. (PubMed, Asian J Psychiatr) - No abstract available

Journal

Plasma Protein Patterns Associated with Paliperidone Palmitate Maintenance Therapy in Schizophrenia: A Prospective Cohort Study. (PubMed, CNS Drugs) - "This study reveals transition-associated proteomic signatures in schizophrenia, identifying protein markers that facilitate subgroup stratification and serve as treatment-emergent companion biomarkers to monitor pharmacodynamic shifts during therapeutic transition to PP1M injection therapy."

Journal • CNS Disorders • Psychiatry • Schizophrenia • ANXA1 • ANXA11 • CLEC5A • CRKL

Efficacy and Safety of TV-46000 and Second-Generation Long-Acting Injectable Antipsychotics for Schizophrenia: A Systematic Literature Review and Network Meta-Analysis of Randomized Controlled Trials. (PubMed, Adv Ther) - "TV-46000 q1m and q2m demonstrated comparable efficacy and safety to second-generation LAIs approved in Canada and used for maintenance treatment of schizophrenia."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Pain • Psychiatry • Schizophrenia

Substance Misuse To Psychosis for Stimulants (clinicaltrials.gov) - P2/3 | N=165 | Completed | Sponsor: The University of Hong Kong | Recruiting ➔ Completed | N=240 ➔ 165

Enrollment change • Trial completion • CNS Disorders • Psychiatry • Schizophrenia