Trial reportThe international journal of neuropsychopharmacology2022
A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia.
Trial report in The international journal of neuropsychopharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03345342 (A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation), which is not on this map. Cited by 34 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
Who cites it
34 citing papers in PubMed, 60 citations in OpenAlex.
- Weight and metabolic changes in patients with schizophrenia treated with paliperidone palmitate 6-month formulation versus paliperidone palmitate 3-month formulation: a post-hoc analysis.The international journal of neuropsychopharmacology · 2026Trial
- Three-Year Outcomes of 6-Month Paliperidone Palmitate in Adults With Schizophrenia: An Open-Label Extension Study of a Randomized Clinical Trial.JAMA network open · 2024Trial
- Model-Informed Clinical Development of 6-Monthly Injection of Paliperidone Palmitate in Patients with Schizophrenia: Dosing Strategies Guided by Population Pharmacokinetic Modeling and Simulation (Part II).European journal of drug metabolism and pharmacokinetics · 2024Trial
- Model-Informed Clinical Development of Once-Every-6-Month Injection of Paliperidone Palmitate in Patients with Schizophrenia: A Pharmacometric Bridging Approach (Part I).European journal of drug metabolism and pharmacokinetics · 2024Trial
- Relapse Rates With Paliperidone Palmitate in Adult Patients With Schizophrenia: Results for the 6-Month Formulation From an Open-label Extension Study Compared to Real-World Data for the 1-Month and 3-Month Formulations.The international journal of neuropsychopharmacology · 2024Trial
- Long-Term Efficacy and Safety of Paliperidone 6-Month Formulation: An Open-Label 2-Year Extension of a 1-Year Double-Blind Study in Adult Participants With Schizophrenia.The international journal of neuropsychopharmacology · 2023Trial
- Aripiprazole two-month long-acting injectable may increase time to readmission compared to aripiprazole one-month in patients with schizophrenia and schizoaffective disorder.Schizophrenia research · 2026Article
- Article
- Redefining long-acting injectables: the emerging role of extracellular vesicles in sustained drug delivery.Drug delivery and translational research · 2026Review
- Are Depot Antipsychotics Ever Self-Tapering? Exploring the Discontinuation of Long-Acting Injectable Psychosis Drugs and Those With Delayed Onset Through In Silico Modelling.Schizophrenia bulletin open · 2026Article
- Advances in implementation strategies for treatment adherence in schizophrenia: a narrative review.Frontiers in psychiatry · 2026Review
- Comparison of Side Effects Between 3-Monthly and 1-Monthly Paliperidone Palmitate Formulations in Patients With Schizophrenia.Human psychopharmacology · 2026Article
- Treatment continuation and factors associated with discontinuation with 3-month paliperidone palmitate in patients with schizophrenia: aFrontiers in psychiatry · 2026Article
- Risk Factors for Relapse of Schizophrenia in the Elderly During the Maintenance Phase: A Matched Case-Control Study.Alpha psychiatry · 2025Article
- Long-Term Symptomatic and Functional Remission with Paliperidone Palmitate 6-Monthly Treatment in Schizophrenia: A 3-Year Post-Hoc Analysis.Neuropsychiatric disease and treatment · 2025Article
- One-Year Evaluation of Paliperidone Palmitate 6-Monthly: Satisfaction and Perceived Effectiveness Among Patients, Relatives, and Clinicians.Patient preference and adherence · 2025Article
- Long-term effectiveness, adherence and safety of twice-yearly paliperidone-palmitate long acting-injectable in patients with schizophrenia in Europe: 2-year mirror-image data from the paliperdone-2 per year study (P2Y).Frontiers in psychiatry · 2025Article
- Effect of comprehensive intervention model based on drug-psychology-society-skills on medication compliance and cognitive ability of chronic schizophrenia patients.World journal of psychiatry · 2024Article
- Clinical effectiveness of paliperidone palmitate 3-monthly and 1-monthly as monotherapy in patients with schizophrenia: A retrospective cohort study based on the Medicaid claims database.Neuropsychopharmacology reports · 2024Article
- Does Slow and Steady Win the Race? Rates of Antipsychotic Discontinuation, Antipsychotic Dose, and Risk of Psychotic Relapse.Schizophrenia bulletin · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis double-blind (DB), randomized, parallel-group study was designed to evaluate efficacy and safety of paliperidone palmitate 6-month (PP6M) formulation relative to paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia.
methodsFollowing screening, patients entered an open-label (OL) maintenance phase and received 1 injection cycle of paliperidone palmitate 1-month (PP1M; 100 or 150 mg eq.) or PP3M (350 or 525 mg eq.). Clinically stable patients were randomized (2:1) to receive PP6M (700 or 1000 mg eq., gluteal injections) or PP3M (350 or 525 mg eq.) in a 12-month DB phase; 2 doses of PP6M (corresponding to doses of PP1M and PP3M) were chosen.
resultsOverall, 1036 patients were screened, 838 entered the OL phase, and 702 (mean age: 40.8 years) were randomized (PP6M: 478; PP3M: 224); 618 (88.0%) patients completed the DB phase (PP6M: 416 [87.0%]; PP3M: 202 [90.2%]). Relapse rates were PP6M, 7.5% (n = 36) and PP3M, 4.9% (n = 11). The Kaplan-Meier estimate of the difference (95% CI) between treatment groups (PP6M - PP3M) in the percentages of patients who remained relapse free was -2.9% (-6.8%, 1.1%), thus meeting noninferiority criteria (95% CI lower bound is larger than the pre-specified noninferiority margin of -10%). Secondary efficacy endpoints corroborated the primary analysis. Incidences of treatment-emergent adverse events were similar between PP6M (62.1%) and PP3M (58.5%). No new safety concerns emerged.
conclusionsThe efficacy of a twice-yearly dosing regimen of PP6M was noninferior to that of PP3M in preventing relapse in patients with schizophrenia adequately treated with PP1M or PP3M.
trial registrationClinical Trials.gov identifier: NCT03345342.
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