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Comparing two transitioning strategies to paliperidone palmitate once-every-6-months.
CNS Spectr
November 2024
ApotheCom Associates LLC, Yardley, USA.
Background: A double-blind, randomized, active-controlled, parallel-group, noninferiority trial (NCT03345342) demonstrated that paliperidone palmitate once-every-6-months (PP6M) was noninferior to paliperidone palmitate once-every-3-months (PP3M) in preventing relapse in clinically stable adults with schizophrenia. This post hoc analysis assessed efficacy and safety following transition to PP6M from paliperidone once-monthly (PP1M) versus PP3M.
Methods: Adults with schizophrenia who were clinically stable on moderate/high doses of PP1M or PP3M were randomly assigned 1:2 to dorsogluteal PP3M or PP6M treatment for 12 months.
Assessment of CD8 T-cell mediated immunity in an influenza A(H3N2) human challenge model in Belgium: a single centre, randomised, double-blind phase 2 study.
Lancet Microbe
July 2024
Biodefense Advanced Research and Development Authority, US Department of Health and Human Services, Washington, DC, USA.
Background: Protection afforded by inactivated influenza vaccines can theoretically be improved by inducing T-cell responses to conserved internal influenza A antigens. We assessed whether, in an influenza controlled human infection challenge, susceptible individuals receiving a vaccine boosting T-cell responses would exhibit lower viral load and decreased symptoms compared with placebo recipients.
Methods: In this single centre, randomised, double-blind phase 2 study, healthy adult (aged 18-55 years) volunteers with microneutralisation titres of less than 20 to the influenza A(H3N2) challenge strain were enrolled at an SGS quarantine facility in Antwerp, Belgium.
Real-World Effectiveness of Repeated Ketamine Infusions for Treatment-Resistant Bipolar Depression.
Focus (Am Psychiatr Publ)
October 2023
Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada (Fancy, Rodrigues, Di Vicenzo, Sethi, Gill, Tabassum, Mckenzie, Phan, McIntyre, Rosenblat); Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada (Fancy, Gill, McIntyre, Rosenblat); Braxia Scientific, Braxia Health, Canadian Rapid Treatment Centre of Excellence, Mississauga, Ontario, Canada (Chau, McIntyre, Rosenblat); Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada (Sethi, Husain, McIntyre, Rosenblat); Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada (Husain); Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada (McIntyre, Rosenblat); Brain and Cognition Discovery Foundation, Toronto, Ontario, Canada (McIntyre).
Background: Clinical trials have demonstrated rapid antidepressant effects with intravenous (IV) ketamine for major depressive disorder, with relatively less research specifically for bipolar depression. Herein, we describe the real-world effectiveness of repeated ketamine infusions for treatment-resistant bipolar depression.
Methods: This study was conducted in a community clinic in Mississauga, Ontario (Canadian Rapid Treatment Centre of Excellence; Braxia Health).
Efficacy and Safety of Xanomeline-Trospium Chloride in Schizophrenia: A Randomized Clinical Trial.
JAMA Psychiatry
August 2024
Karuna Therapeutics, Boston, Massachusetts.
Article Synopsis
- There is a critical demand for new antipsychotic medications that are more effective and have fewer side effects; xanomeline, a new muscarinic receptor agonist, shows promise in this area, especially when paired with trospium chloride to minimize side effects.
- The EMERGENT-3 trial tested xanomeline-trospium against a placebo in adults with schizophrenia experiencing acute psychosis, taking place at multiple sites in the US and Ukraine from April to December 2022.
- The study aimed to measure changes in psychiatric symptoms using the Positive and Negative Syndrome Scale (PANSS) and assess safety, with results expected to contribute to new treatment options for schizophrenia.
Evaluating the 6-month formulation of paliperidone palmitate: a twice-yearly injectable treatment for schizophrenia in adults.
Expert Rev Neurother
April 2024
Department of Biomedical and Clinical Sciences (DIBIC), Department of Psychiatry, ASST Fatebenefratelli-Sacco, University of Milan, Milan, Italy.
Introduction: Paliperidone Palmitate is the only antipsychotic that has been developed in three different intramuscular long-acting injectable (LAI) dosing regimen: monthly (PP1M), quarterly (PP3M), and from 2020 also twice-yearly (PP6M). The latter was approved for the maintenance treatment of adults with schizophrenia and clinically stabilized with PP1M or PP3M.
Areas Covered: Data from studies evaluating efficacy in the maintenance treatment of schizophrenia with PP6M are reviewed.
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