Invega Sustenna (paliperidone palmitate extended-release 1-month injection) / J&J - LARVOL DELTA

Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia (clinicaltrials.gov) - P=N/A | N=256 | Completed | Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

New trial • CNS Disorders • Psychiatry • Schizophrenia

Comparison of dopamine D2 receptor occupancy profiles between risperidone ism versus oral risperidone and monthly paliperidone palmitate based on population pharmacokinetic modelling and simulations. (PubMed, Expert Rev Clin Pharmacol) - "A much faster onset of action and better D2RO coverage during the dosing interval was predicted for Risperidone-ISM® versus PP1M. Simulations suggest that Risperidone-ISM® compares favorably with high doses of OR and PP1M, making it an effective therapeutic strategy for rapid and sustained symptom reduction."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia • DRD2

Assessment of prolactin levels and sexual dysfunction in patients on long-acting risperidone ISM vs monthly paliperidone palmitate. (PubMed, Span J Psychiatry Ment Health) - "Risperidone ISM may be associated with a more favourable prolactin profile in women vs PP. Findings support the relevance of sex and adjunctive strategies in managing antipsychotic-induced endocrine side effects."

Journal • CNS Disorders • Endocrine Disorders • Psychiatry • Schizophrenia • Sexual Disorders

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

Psychotropic-associated delusional pseudo-gender dysphoria: a case report. (PubMed, BMC Psychiatry) - "This is the first case to report on the contribution of psychotropics in the development of gender dysphoric delusions and is also the first to report on two different types of gender dysphoric delusions occurring in the same patient at different times, with initial delusions of simultaneously belonging to both genders and then delusions of belonging to the opposite gender only."

Journal • Bipolar Disorder • CNS Disorders • Psychiatry • Schizophrenia • Women's Health

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

Use of monthly injectable paliperidone in a patient with borderline personality disorder (ECNP 2025) - " Monthly paliperidone was prescribed for a patient with borderline personality disorderand a history of severe emotional dysregulation, resulting in functional impairment and requiring drug intervention... The use of long-acting antipsychotics in patients who require medication to control emotional dysregulation is well established, although some evidence shows conflicting efficacy results. Low adherence to medication should always be considered in patients with poor response, even before diagnosing someone as refractory or pseudorefractory. Because they ensure a stable serum level, IAPs are recommended in the main guidelines for schizophrenia."

Clinical • Borderline Personality Disorder • CNS Disorders • Mood Disorders • Personality Disorder • Psychiatry • Schizophrenia

Use of long-acting injectable paliperidone in patients with ASD + ADHD (ECNP 2025) - " Monthly paliperidone was prescribed for a total of 5 patients diagnosed with ASD and/or ADHD and a history of severe emotional dysregulation, resulting in functional impairment and requiring drug intervention.The patients were monitored for 6 months, and psychosocial rehabilitation therapies were also provided in a day hospital (such as occupational therapy, structured psychotherapy, manual therapies, etc.).The initial regimen was prescribed (Paliperidone 150mg on day 1, intramuscular in deltoid, followed by 100mg on day 8).Some other medical intervention was prescribed according to the medical judgment, but the only antipsychotic used was monthly paliperidone... The use of long-acting antipsychotics in patients who require medication to control emotional dysregulation is well established, although some evidence shows conflicting efficacy results. Low adherence to medication should always be considered in patients with poor response, even before diagnosing someone as..."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry • Psychomotor Agitation • Schizophrenia

Shifting the paradigm: the use of long-acting atypical antipsychotics in acute care (ECNP 2025) - "There is one study evaluating the use of aripiprazole once-monthly (AOM) versus placebo in acute inpatients [1]. Loading strategies have since been developed for AOM [2], and aripiprazole two-monthly (ATM) with two simultaneous injections and single oral dose, which have been shown to achieve therapeutic plasma levels within 24 hours. The two loading deltoid doses of 150 and 100 mg paliperidone palmitate once-monthly (PP1M) can be completed within 4 days, and oral supplementation is not required [3]... The pharmacokinetics of atypical LAIs and new loading strategies with the rapid achievement of therapeutic plasma levels suggest the potential consideration of earlier initiation in a variety of acute care settings. Further research is recommended to evaluate safe and effective protocols for early initiation of LAIs which may improve the care pathways of hospital and community management of schizophrenia. Guidelines should be developed or updated to incorporate the most..."

CNS Disorders • Psychiatry • Schizophrenia

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

Prolactin response to six-month paliperidone palmitate. Preliminary results (ECNP 2025) - "One such strategy is to add low-dose aripiprazole to the selected antipsychotic regimen. Newer antipsychotics, particularly risperidone, amisulpride, and paliperidone, and older antipsychotics, particularly chlorpromazine, haloperidol, and sulpiride, increase prolactin levels with significant side effects...In other words, the mean difference in PRL values between patients treated with monthly paliperidone (PP1M) and those same patients treated with six-month paliperidone (PP6M) is 35.57 μg/L. This difference is due to the change in treatment and not to chance. Treatment with six-month paliperidone (PP6M) significantly improves blood prolactin levels, effectively reducing them by half."

CNS Disorders • Mental Retardation • Psychiatry • PRL

An open-label, randomized, multicenter, steady-state bioequivalence study of paliperidone palmitate extended-release injectable suspension in subjects with schizophrenia (ECNP 2025) - "The results from this study demonstrate that Mylan's Paliperidone Palmitate Extended-release Injectable Suspension, is bioequivalent to Janssen's Invega Sustenna®, following six monthly intramuscular doses of 156 mg administered to patients with schizophrenia at steady-state and provides clinicians another treatment option and may improve access to patients."

Clinical • CNS Disorders • Psychiatry • Schizophrenia

Use of high doses of second-generation long-acting antipsychotics in patients with resistant schizophrenia. Treatment compliance, effectiveness, and tolerability (ECNP 2025) - "Methods A 72-month observational, mirror-image study of patients with severe (Clinical Global Impression-Severity, CGI-S ≥ 5) resistant schizophrenia receiving treatment with ≥75 mg of risperidone long-acting injectable (RLAI) (N = 60), ≥175 mg of monthly paliperidone palmitate (PP) (N = 60), and ≥600 mg of aripiprazole once-monthly (AOM) (N = 30). These SGA LAI treatments improved treatment adherence and outcomes (hospitalizations, suicide attempts, clinical severity, disability) of the patients, with good tolerability, helping them to achieve clinical stabilization and better functioning. Therefore, we suggest that, in some illness-critical conditions, high doses of SGA LAIs could represent an alternative to clozapine, to date the only therapy for resistant schizophrenia"

Clinical • Compliance • CNS Disorders • Psychiatry • Schizophrenia

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

Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia (clinicaltrials.gov) - P4 | N=120 | Not yet recruiting | Sponsor: Jiangsu Province Nanjing Brain Hospital | Initiation date: Jul 2025 ➔ Oct 2025

Trial initiation date • 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

Switching Patients with Schizophrenia from Intramuscular Paliperidone Palmitate Once Monthly to TV-46000, a Long-Acting Subcutaneous Antipsychotic: Population Pharmacokinetic-Based Strategies. (PubMed, Adv Ther) - "Switching to TV-46000 125 mg q1m 4 weeks after the last PP1m 234-mg injection yielded generally comparable pharmacokinetic parameters at steady state. The same was true for other TV-46000 q1m or q2m dosages and equivalent dosages of PP1m. Clinician discretion will ultimately determine how to switch on the basis of factors such as patient preference, convenience, and concerns about tolerability or symptom breakthrough."

Journal • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Multicenter Bioavailability Study of Long-Acting Paliperidone in Patients With Schizophrenia or Schizoaffective Disorder. (PubMed, J Clin Psychopharmacol) - "The test formulation, Vegapali, proved to be bioequivalent to the reference product, supporting its use as an alternative LAI treatment for schizophrenia. This finding guarantees the therapeutic equivalence of both formulations, expanding access to effective and sustained treatment options for schizophrenia management."

Journal • CNS Disorders • Psychiatry • Schizophrenia

Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia (clinicaltrials.gov) - P4 | N=120 | Not yet recruiting | Sponsor: Jiangsu Province Nanjing Brain Hospital

New P4 trial • 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 of paliperidone palmitate once-monthly (PP1M) in improving social functioning and reducing caregiver burden in patients with schizophrenia: a six-month follow-up study. (PubMed, BMC Psychiatry) - "PP1M treatment effectively controlled symptoms, improved social functioning, and reduced caregiver burden in schizophrenia patients. The significant correlation between symptom improvement and functional recovery suggests PP1M may substantially support long-term rehabilitation and quality of life enhancement."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia