- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00784238
Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants (Power)
7. februar 2014 opdateret af: 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).
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
289
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Busan, Korea, Republikken
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Changnyeong-Gun, Korea, Republikken
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Chonju, Korea, Republikken
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Chun-An, Korea, Republikken
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Chungcheongbuk-Do, Korea, Republikken
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Dae-Jeon, Korea, Republikken
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Daegu, Korea, Republikken
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Daejeon, Korea, Republikken
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Hwasun Gun, Korea, Republikken
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Iksan, Korea, Republikken
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Kwangjoo, Korea, Republikken
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Naju, Korea, Republikken
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2008
Primær færdiggørelse (Faktiske)
1. december 2010
Studieafslutning (Faktiske)
1. januar 2011
Datoer for studieregistrering
Først indsendt
31. oktober 2008
Først indsendt, der opfyldte QC-kriterier
31. oktober 2008
Først opslået (Skøn)
2. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
27. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. februar 2014
Sidst verificeret
1. februar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Skizofrenispektrum og andre psykotiske lidelser
- Skizofreni
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Depressive midler til centralnervesystemet
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Dopaminmidler
- Serotonin 5-HT2-receptorantagonister
- Serotonin-antagonister
- Dopamin D2-receptorantagonister
- Dopamin-antagonister
- Paliperidon Palmitat
Andre undersøgelses-id-numre
- CR015391
- R076477SCH4028
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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