Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants (PASS)
3 septembre 2014 mis à jour par: Janssen Korea, Ltd., Korea
An Open-label Prospective, Non-comparative Study to Evaluate the Subjective Experiences Upon Transition to Paliperidone Extended Release(ER) in Subjects With Schizophrenia
The purpose of this study is to investigate the efficacy of flexibly dosed paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in improving or maintaining the subjective symptoms of the participants in three participants' groups (that is, by the reason to switch: lack of efficacy group, lack of tolerability group, and lack of compliance group) who switched from other previous antipsychotic drugs to paliperidone extended-release tablets at flexible doses.
Aperçu de l'étude
Description détaillée
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended-release (ER) in participants switching from the previous oral antipsychotic to flexibly dosed paliperidone ER.
The total study duration will be approximately of 24 weeks per participant.
The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (24 weeks).
Efficacy will primarily be evaluated by change from baseline in symptom checklist 90-R (SCL90-R) at Week 24.
Participants' safety will be monitored throughout the study.
Type d'étude
Interventionnel
Inscription (Réel)
387
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Chunchun, Corée, République de
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Incheon, Corée, République de
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Inchun, Corée, République de
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Kangwondo, Corée, République de
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Kyunggido, Corée, République de
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Kyungki, Corée, République de
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Kyunki, Corée, République de
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Seoul, Corée, République de
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Childbearing potential women who consent to the use of the consistently permissible contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
- Participants who are compliant with self-medication or can receive consistent help or support
- Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening (1) Group of lack of efficacy: The antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: The antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: The antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
Exclusion Criteria:
- Participants with the past history of neuroleptic malignant syndrome (NMS)
- Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)
- Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile
- Female participants who are pregnant or are breast feeding
- Participants who have participated in any investigational drug trial within 1 month prior to the screening visit
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Paliperidone
Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
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Paliperidone oral tablet will be administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Délai: Baseline and Week 24
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The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI).
SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely).
Total scale score range from 0 to 360.
Higher scores indicate worsening of disease.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Délai: Baseline and Week 24
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The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior.
The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains.
Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Délai: Baseline and Week 24
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The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants.
The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF).
The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience).
SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Délai: Baseline and Week 24
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Sleep quality was assessed by an 11-point visual analog scale.
Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Scores were averaged for the previous 7 days.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Délai: Baseline and Week 24
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Daytime Drowsiness was assessed by an 11-point visual analog scale.
Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Scores were averaged for the previous 7 days.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Krawiecka Scale Score at Week 24
Délai: Baseline and Week 24
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Psychopathology of participants was assessed by Krawiecka scale.
Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16.
Higher score indicates worsening of disease.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
Délai: Baseline and Week 24
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The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.
A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants".
Higher scores indicate worsening.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24
Délai: Baseline and Week 24
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The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Change from Baseline was calculated as value at Baseline minus value at Week 24.
Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
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Baseline and Week 24
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2008
Achèvement primaire (Réel)
1 septembre 2010
Achèvement de l'étude (Réel)
1 octobre 2010
Dates d'inscription aux études
Première soumission
25 septembre 2008
Première soumission répondant aux critères de contrôle qualité
26 septembre 2008
Première publication (Estimation)
29 septembre 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 septembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 septembre 2014
Dernière vérification
1 septembre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Spectre de la schizophrénie et autres troubles psychotiques
- La schizophrénie
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Dépresseurs du système nerveux central
- Agents antipsychotiques
- Agents tranquillisants
- Médicaments psychotropes
- Agents de sérotonine
- Agents dopaminergiques
- Antagonistes des récepteurs de la sérotonine 5-HT2
- Antagonistes de la sérotonine
- Antagonistes des récepteurs de la dopamine D2
- Antagonistes de la dopamine
- Palmitate de palipéridone
Autres numéros d'identification d'étude
- CR015253
- PAL-KOR-4003
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