A5064130565- Schizophrenia research and treatment
- Pharmaceutical studies and practices
- Mental Health and Psychiatry
- Pharmacovigilance and Adverse Drug Reactions
- Bipolar Disorder and Treatment
- Botulinum Toxin and Related Neurological Disorders
- Pharmaceutical Practices and Patient Outcomes
- Pain Mechanisms and Treatments
- Attention Deficit Hyperactivity Disorder
- Pain Management and Opioid Use
- HIV Research and Treatment
- Intramuscular injections and effects
- Statistical Methods in Clinical Trials
- Pediatric Pain Management Techniques
- Neurological disorders and treatments
- Tryptophan and brain disorders
- Diet and metabolism studies
- Autism Spectrum Disorder Research
- Health Systems, Economic Evaluations, Quality of Life
- Mental Health Treatment and Access
- Treatment of Major Depression
- Epilepsy research and treatment
- Cardiovascular Syncope and Autonomic Disorders
Janssen (Belgium)
2019-2023
Janssen Scientific Affairs (United States)
2016-2023
Janssen (United States)
2016-2023
Universidad de Oviedo
2019
Centro de Investigación Biomédica en Red de Salud Mental
2019
Article AbstractBackground: Previous studies have suggested that clozapine is associated with increases in both weight and serum triglyceride (but not cholesterol) levels. Because of the pharmacologic similarities between olanzapine, we decided to evaluate if olanzapine use was an increase triglycerides.Method: Twenty-five inpatients (21 men, 4 women) were treated their outcomes tracked prospectively a medication utilization evaluation study.Results: After 12 weeks on mean ± SD dose 13.8 4.4...
This double-blind (DB), randomized, parallel-group study was designed to evaluate efficacy and safety of paliperidone palmitate 6-month (PP6M) formulation relative 3-month (PP3M) in patients with schizophrenia.Following screening, entered an open-label (OL) maintenance phase received 1 injection cycle 1-month (PP1M; 100 or 150 mg eq.) PP3M (350 525 eq.). Clinically stable were randomized (2:1) receive PP6M (700 1000 eq., gluteal injections) a 12-month DB phase; 2 doses (corresponding PP1M...
Paliperidone palmitate 6-month (PP6M) demonstrated noninferiority to paliperidone 3-month in preventing relapse patients with schizophrenia a phase 3 double-blind (DB) study (NCT03345342). Here, we report long-term efficacy and safety results from 2-year single-arm, open-label extension (OLE; NCT04072575) of this DB study.Participants who completed the without were enrolled followed-up every months up 2 years. Participants received 4 PP6M gluteal injections (700/1000 mg eq.) at baseline,...
With more long-acting injectable (LAI) antipsychotics available for treating schizophrenia, each with variable durations of action (2 weeks to 3 months), it is important have clear management strategies patients developing breakthrough psychotic symptoms or experiencing symptomatic worsening on LAIs. However, no treatment guidelines clinical practice pathways exist; health-care providers must rely their own judgment manage these patients. This article provides practical recommendations—based...
Purpose To evaluate injection site reactions and pain following paliperidone palmitate 1-month (PP1M) 3-month (PP3M) administration using safety data of double-blind (DB), noninferiority study. Methods Patients (n = 1,429) with schizophrenia, treated PP1M (50–150 mg-eq, 17-week open-label [OL] phase) were randomized to or PP3M in 48-week DB phase. Findings injections well tolerated. Incidence induration, redness, swelling low both phases (OL: 9–12%; DB: 7–13%), mostly mild groups. Mean (SD)...
The aim of this study was to evaluate the safety 3-monthly paliperidone palmitate (PP3M) vs once-monthly (PP1M) treatment with regard extrapyramidal symptom (EPS)-related treatment-emergent adverse events (TEAEs) in patients schizophrenia, previously stabilized on PP1M treatment.Data overall incidence, time onset (TTO), and resolution (TTR) EPS-related TEAEs (overall, subclasses such as dyskinesia, dystonia, hyperkinesia, parkinsonism, tremor) from a randomized double-blind (DB)...
Introduction Paliperidone palmitate 6-month (PP6M), administered twice-yearly, demonstrated non-inferiority to paliperidone 3-month (PP3M) in preventing relapse patients with schizophrenia a phase-3 randomized, double-blind (DB) global study. 1 We report results of 2-year single-arm, open-label extension (OLE) this study (NCT04072575). Objectives To assess long-term efficacy and safety PP6M schizophrenia. Methods Patients who completed DB without were enrolled followed up every 3 months for...
Objective: To assess the efficacy and safety of paliperidone palmitate (PP) long-acting injectable antipsychotic (LAI) versus oral (OAP) treatment in adult patients diagnosed with schizophrenia (per DSM-IV or DSM-5 criteria) varying duration illness (0-3 years > 3 years).Methods: Patient-level data from PRIDE, PROSIPAL, DREaM studies were included a post hoc analysis. Efficacy outcomes, including relapse assessments, Personal Social Performance scale scores, Medication Satisfaction...
This retrospective cohort study evaluated real-world data on relapses in adult patients with schizophrenia who transitioned to long-acting injectable paliperidone palmitate once-every-3-months (PP3M) following treatment once-monthly (PP1M).
Conclusion:Clinically relevant improvements in psychopathology were observed patients with acute schizophrenia treated brexpiprazole or aripiprazole.Brexpiprazole was well tolerated a lower incidence of EPS-related adverse events than aripiprazole.
Early Post-Marketing Phase Vigilance (EPPV) is a unique system that encourages reporting of serious adverse reactions for medications newly introduced to Japan. When once-monthly paliperidone palmitate formulation (PP1M) was in Japan 2013, EPPV detected signal increased mortality, but this not subsequently confirmed. To clarify whether reflected event or an atypically high baseline mortality risk among early adopters PP1M, we evaluated the characteristics early, mid, and later PP1M Japanese...
Purpose . This post hoc analysis assessed the importance of proper paliperidone palmitate (PP) dose preparation prior to administration and evaluated injection site reactions after dorsogluteal PP once‐every‐6‐months (PP6M) once‐every‐3‐months (PP3M) formulations from a double‐blind (DB) noninferiority study. Design Methods Clinically stable patients receiving moderate/high doses once‐monthly (PP1M) (156 mg/mL; 234 mg/1.5 mL) or PP3M (546 mg/1.75 mL; 819 mg/2.63 were randomly assigned 2:1...
Symptomatic remission (SR) is an important outcome for schizophrenia patients [1]. In pivotal trials, paliperidone 3-monthly formulation (PP3M) demonstrated favorable efficacy and tolerability in schizophrenia, including achievement of SR [2–4]. However, due to the selective nature randomized clinical populations studied may not be entirely representative real life. A prospective, single-arm, open-label, 52-week study (REMISSIO) was conducted a naturalistic setting assess impact conversion...