Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants (Power)
7 de fevereiro de 2014 atualizado por: Janssen Korea, Ltd., Korea
An Open-label, Prospective, Non-Comparative Study to Evaluate Subjective Well-Being and Responses in Patients With Schizophrenia Who Had Switched to Paliperidone Extended-Release Tablets
The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Visão geral do estudo
Descrição detalhada
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), and non-comparative study, in participants with schizophrenia.
The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks).
Total study duration per participant will be 96 weeks.
Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores.
Participants' safety will be monitored throughout the study.
Tipo de estudo
Intervencional
Inscrição (Real)
289
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Busan, Republica da Coréia
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Changnyeong-Gun, Republica da Coréia
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Chonju, Republica da Coréia
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Chun-An, Republica da Coréia
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Chungcheongbuk-Do, Republica da Coréia
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Dae-Jeon, Republica da Coréia
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Daegu, Republica da Coréia
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Daejeon, Republica da Coréia
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Hwasun Gun, Republica da Coréia
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Iksan, Republica da Coréia
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Kwangjoo, Republica da Coréia
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Naju, Republica da Coréia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])
- 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-Lack of efficacy, lack of tolerance or lack of compliance
- Participants who are capable of and willing to fill out the questionnaire for themselves
- 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
Exclusion Criteria:
- Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone
- Participants who have taken clozapine within one month before screening
- 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)
- Participants with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Paliperidone
Paliperidone Extended-Release (ER) oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.
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Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Prazo: 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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Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
Prazo: 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.
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Week 24
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Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Prazo: 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.
Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement 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 Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Prazo: 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.
Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement 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 Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Prazo: 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.
Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement 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 Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Prazo: 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.
Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement 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 Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Prazo: 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.
Social integration subscale score ranges from 0 to 24 and higher score indicates improvement 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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Drug Attitude Inventory (DAI-10) Total Score at Week 24
Prazo: Week 24
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The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants.
It is the binary scale assessing the participant's subjective response.
A 'compliant' response is scored as +1; a dysphoric response is scored as -1.
A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).
The final score is the grand total of the positive and negative points.
Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
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Week 24
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Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24
Prazo: Baseline and Week 24
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The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants.
It is the binary scale assessing the participant's subjective response.
A 'compliant' response is scored as +1; a dysphoric response is scored as -1.
A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant).
The final score is the grand total of the positive and negative points.
Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Prazo: 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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Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Prazo: 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 Krawiecka Scale Score at Week 24
Prazo: 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 Sleep Quality Based on Visual Analog Scale at Week 24
Prazo: Baseline and Week 24
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Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept.
Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well").
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
Prazo: Baseline and Week 24
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Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept.
Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well").
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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Colaboradores e Investigadores
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Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de abril de 2008
Conclusão Primária (Real)
1 de dezembro de 2010
Conclusão do estudo (Real)
1 de janeiro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
31 de outubro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de outubro de 2008
Primeira postagem (Estimativa)
2 de novembro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
27 de março de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de fevereiro de 2014
Última verificação
1 de fevereiro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Esquizofrenia
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Depressores do Sistema Nervoso Central
- Antipsicóticos
- Agentes Tranquilizantes
- Drogas Psicotrópicas
- Agentes de Serotonina
- Agentes de Dopamina
- Antagonistas do Receptor de Serotonina 5-HT2
- Antagonistas da Serotonina
- Antagonistas do Receptor D2 da Dopamina
- Antagonistas da Dopamina
- Palmitato de Paliperidona
Outros números de identificação do estudo
- CR015391
- R076477SCH4028
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