Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission (PERFECT)
1 de mayo de 2014 actualizado por: Janssen Korea, Ltd., Korea
An Open-Label Prospective, Non-Comparative Study To Explore The Tolerability, Safety and Effectiveness Upon Transition to Paliperidone Slow-Release Tablet in Schizophrenic Patients
The purpose of this study is to investigate the safety and efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Descripción general del estudio
Descripción detallada
This is an open-label, prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia (after switching from the existing drug to paliperidone ER).
The total study duration will be approximately of 48 weeks per participant.
The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (single-oral dose of paliperidone for 48 weeks, dose ranging from 3 to 12 milligram).
Efficacy of the participants will primarily be evaluated by Positive and Negative Syndrome Scale.
Participants' safety will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
190
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Busan, Corea, república de
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Chunjoo, Corea, república de
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Dae-Gu, Corea, república de
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Goyang-Si, Corea, república de
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Ilsan, Corea, república de
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Kyounggi, Corea, república de
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Kyunggi-Do, Corea, república de
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Seoul, Corea, república de
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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)
- Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
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)
- Participants with significant abnormal findings in blood chemistry, hematological and urine analyses which are clinically significant at the investigator's discretion
- Female Participants who are pregnant or are breast feeding
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Paliperidone
Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
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Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
Periodo de tiempo: Baseline and Week 48
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The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control.
The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210.
Higher scores indicate worsening.
Change from Baseline is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48
Periodo de tiempo: Baseline and Week 48
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The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia.
Positive symptoms refer to an excess or distortion of normal functions.
The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Change from Baseline is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48
Periodo de tiempo: Baseline and Week 48
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The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia.
Negative symptoms represent a diminution or loss of normal functions.
The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Change from Baseline is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48
Periodo de tiempo: Baseline and Week 48
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The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms.
The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Change from Baseline is calculated as value at Baseline minus value at Week 48.
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 48
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48
Periodo de tiempo: Baseline and Week 48
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The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function.
Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).
Change from Baseline is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48
Periodo de tiempo: Baseline and Week 48
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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 is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48
Periodo de tiempo: Baseline and Week 48
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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 is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Daytime Drowsiness at Week 48
Periodo de tiempo: Baseline and Week 48
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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 is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Sleep Quality at Week 48
Periodo de tiempo: Baseline and Week 48
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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 is calculated as value at Baseline minus value at Week 48.
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 48
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Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48
Periodo de tiempo: Baseline and Week 48
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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.
Total scale score range from 0 to 360.
Higher scores indicate worsening of disease.
Change from Baseline is calculated as value at Baseline minus value at Week 48.
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 48
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2008
Finalización primaria (Actual)
1 de octubre de 2010
Finalización del estudio (Actual)
1 de diciembre de 2010
Fechas de registro del estudio
Enviado por primera vez
25 de septiembre de 2008
Primero enviado que cumplió con los criterios de control de calidad
26 de septiembre de 2008
Publicado por primera vez (Estimar)
29 de septiembre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
3 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
1 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Espectro de esquizofrenia y otros trastornos psicóticos
- Esquizofrenia
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Agentes de serotonina
- Agentes de dopamina
- Antagonistas del receptor de serotonina 5-HT2
- Antagonistas de serotonina
- Antagonistas del receptor de dopamina D2
- Antagonistas de la dopamina
- Palmitato de paliperidona
Otros números de identificación del estudio
- CR015250
- PAL-KOR-4002
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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