Trial reportThe international journal of neuropsychopharmacology2016
Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study.
Trial report in The international journal of neuropsychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
84 citing papers in PubMed, 3 syntheses or guidelines pooled it, 160 citations in OpenAlex.
- 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.Advances in therapy · 2025Pooled it
- Pharmacological and Somatic Treatments for First-Episode Psychosis and Schizophrenia: Synopsis of the US Department of Veterans Affairs and US Department of Defense Clinical Practice Guidelines.Schizophrenia bulletin · 2025Guideline
- Adverse effects of antipsychotics on sleep in patients with schizophrenia. Systematic review and meta-analysis.Frontiers in psychiatry · 2023Pooled it
- 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 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
- Trial
- 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
- Feasibility study to evaluate capabilities for conducting psychiatric clinical research within the Rwandan mental healthcare system.BMJ open · 2023Trial
- Real-world calibration and transportability of the Disease Recovery Evaluation and Modification (DREaM) randomized clinical trial in adult Medicaid beneficiaries with recent-onset schizophrenia.Journal of managed care & specialty pharmacy · 2023Trial
- A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia.The international journal of neuropsychopharmacology · 2022Trial
- Evaluation of paliperidone palmitate long-acting injectable antipsychotic therapy as an early treatment option in patients with schizophrenia.Early intervention in psychiatry · 2020Trial
- Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy.British journal of clinical pharmacology · 2016Trial
- Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)Trial
- Prolonged Tardive Dyskinesia Induced by Long-Acting Paliperidone Palmitate in Schizophrenia: A Case Report.The American journal of case reports · 2026Article
- 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.Therapeutic advances in psychopharmacology · 2026Article
- Treatment continuation and factors associated with discontinuation with 3-month paliperidone palmitate in patients with schizophrenia: aFrontiers in psychiatry · 2026Article
- 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
- Patient views on paliperidone palmitate 3-monthly: a cross-sectional questionnaire in UK community mental health teams.Therapeutic advances in psychopharmacology · 2026Article
- Comparison of Side Effects Between 3-Monthly and 1-Monthly Paliperidone Palmitate Formulations in Patients With Schizophrenia.Human psychopharmacology · 2026Article
24 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis double-blind, parallel-group, multicenter, phase-3 study was designed to test the noninferiority of paliperidone palmitate 3-month formulation (PP3M) to the currently marketed 1-month formulation (PP1M) in patients (age 18-70 years) with schizophrenia, previously stabilized on PP1M.
methodsAfter screening (≤3 weeks) and a 17-week, flexible-dosed, open-label phase (PP1M: day 1 [150mg eq. deltoid], day 8 [100mg eq. deltoid.], weeks 5, 9, and 13 [50, 75, 100, or 150mg eq., deltoid/gluteal]), clinically stable patients were randomized (1:1) to PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal) or PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal) for a 48-week double-blind phase.
resultsOverall, 1016/1429 open-label patients entered the double-blind phase (PP3M: n=504; PP1M: n=512) and 842 completed it (including patients with relapse). PP3M was noninferior to PP1M: relapse rates were similar in both groups (PP3M: n=37, 8%; PP1M: n=45, 9%; difference in relapse-free rate: 1.2% [95% CI:-2.7%; 5.1%]) based on Kaplan-Meier estimates (primary efficacy). Secondary endpoint results (changes from double-blind baseline in positive and negative symptom score total and subscale scores, Clinical Global Impression-Severity, and Personal and Social Performance scores) were consistent with primary endpoint results. No clinically relevant differences were observed in pharmacokinetic exposures between PP3M and PP1M. Both groups had similar tolerability profiles; increased weight was the most common treatment-emergent adverse event (double-blind phase; 21% each). No new safety signals were detected.
conclusionTaken together, PP3M with its 3-month dosing interval is a unique option for relapse prevention in schizophrenia.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.