A Comparative Efficacy and Safety Study of Long-Acting Risperidone Injection and Risperidone Oral Tablets Among Hospitalized Patients: 12-Week Randomized, Single-Blind Study

Bai, Yiping; Chen, T. T.; Wu, Bing-Ruey; Hung, Chih Hung; Lin, Wen Kuo; Hu, Tsung‐Ming; Lin, Cheng‐I; Chou, Pesus

doi:10.1055/s-2006-946703

Cited by 60 publications

(33 citation statements)

References 18 publications

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“…Despite these apparent advantages, clinical trials comparing LAI and oral antipsychotics have produced inconsistent results. [16][17][18][19][20][21] We hypothesize that the inconsistencies in these reports might be a consequence of the study designs chosen for these comparisons and, possibly, a failure to follow a broad spectrum of patients using measures that reflect an adequate breadth of real-world outcomes. 22 We describe a study, Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE), that compares oncemonthly paliperidone palmitate with daily oral antipsychotics in patients with schizophrenia who are at risk for relapse.…”

mentioning

confidence: 99%

Real-World Outcomes of Paliperidone Palmitate Compared to Daily Oral Antipsychotic Therapy in Schizophrenia

Alphs

Benson²,

Cheshire-Kinney³

et al. 2015

J. Clin. Psychiatry

126

108

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mentioning

confidence: 99%

Real-World Outcomes of Paliperidone Palmitate Compared to Daily Oral Antipsychotic Therapy in Schizophrenia

Alphs

Benson²,

Cheshire-Kinney³

et al. 2015

J. Clin. Psychiatry

126

108

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“…En termes de présence au niveau des récepteurs, il s'agit d'une pharmacodynamique très différente de celle des formes orales. Cela signifie moins de périodes avec des concentrations infra-thérapeutiques, ainsi que moins de périodes avec des concentrations excessives responsables d'effets indésirables [40], tels que ceux liés à une occupation des récepteurs D2 supérieure à 80 % [41]. La rispéridone IAP a été le premier APAP pour lequel il a été suggéré que les effets indésirables comme les SEP étaient plus rares avec la forme IAP qu'avec le même médicament per os [42][43][44].…”

Section: éVolution Des Objectifs Thérapeutiquesunclassified

Histoire des traitements antipsychotiques à action prolongée dans la schizophrénie

Crocq¹

2015

L'Encéphale

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“…This, in turn, could decrease the likelihood of institutionalization in hospitals and incarceration. Studies comparing long-acting injectable versus oral antipsychotic treatment have provided inconsistent results, [6][7][8][9][10][11][12][13][14][15] with some indication that demonstrating a differential effectiveness among these formulations is better established with a more pragmatic clinical trial design than with one that is more explanatory. [16][17][18][19] With this in mind, we designed the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study (ClinicalTrials.gov identifier: NCT01157351) to compare once-monthly paliperidone palmitate and daily oral antipsychotics in real-world schizophrenia, as defined by subject inclusion criteria, treatment, and outcomes.…”

Section: Rationalementioning

confidence: 99%

Design and Rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) Study

Alphs¹,

Mao²,

Rodriguez³

et al. 2014

J. Clin. Psychiatry

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Background: Public health considerations require that clinical trials address the complex "real-world" needs of patients with chronic illnesses. This is particularly true for persons with schizophrenia, whose management is frequently complicated by factors such as comorbid substance abuse, homelessness, and contact with the criminal justice system. In addition, barriers to obtaining health care in the United States often prevent successful community reentry and optimal patient management. Further, nonadherence to treatment is common, and this reinforces cycles of relapse and recidivism.Long-acting injectable antipsychotic therapy may facilitate continuity of treatment and support better outcomes, particularly in patients who face these challenges. Clinical trials with classical explanatory designs may not be the best approaches for evaluating these considerations. We describe the design and rationale of a novel trial that combines both explanatory and pragmatic design features and studies persons with schizophrenia who face these challenges. Design and Rationale:The Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study is a prospective, open-label, randomized, 15-month study conducted between May 5, 2010, and December 9, 2013, comparing long-acting injectable paliperidone palmitate and oral antipsychotic medications in subjects with schizophrenia (according to DSM-IV criteria). Investigators and subjects had broad flexibility for treatment decision-making, thus making it a model that better reflects real-world practice. The primary end point was time to treatment failure, defined as arrest/incarceration psychiatric hospitalization; suicide; treatment discontinuation or supplementation due to inadequate efficacy, safety, or tolerability; or increased psychiatric services to prevent hospitalization. This end point was adjudicated by a blinded event monitoring board. Patients were followed to the 15-month end point, regardless of whether they were maintained on their initial randomized treatment. This article provides some of the reasoning behind the authors' choices when combining features from both explanatory and pragmatic approaches to this trial's design. Conclusions:The PRIDE study incorporates real-world design features in a novel, prospective, comparative study of long-acting injectable and oral antipsychotics in persons with schizophrenia who have had recent contact with the criminal justice system. Insights provided should help the reader to better understand the need for more real-world approaches for clinical studies and how a broader approach can better aid clinical treatment and public health decision-making.Trial Registration: ClinicalTrials.gov identifier: NCT01157351

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A Comparative Efficacy and Safety Study of Long-Acting Risperidone Injection and Risperidone Oral Tablets Among Hospitalized Patients: 12-Week Randomized, Single-Blind Study

Abstract: The results indicated that with optimal controlling of drug compliance among hospitalized patients, RLAI showed no benefit of efficacy over oral risperidone, but with advantages of improved side-effect profiles, social life ratings, and reduced prolactin levels.

Cited by 60 publications

References 18 publications

Real-World Outcomes of Paliperidone Palmitate Compared to Daily Oral Antipsychotic Therapy in Schizophrenia

Real-World Outcomes of Paliperidone Palmitate Compared to Daily Oral Antipsychotic Therapy in Schizophrenia

Histoire des traitements antipsychotiques à action prolongée dans la schizophrénie

Design and Rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) Study

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