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Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission (PERFECT)

1 maj 2014 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

190

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Korea, Republiken av
      • Busan, Korea, Republiken av
      • Chunjoo, Korea, Republiken av
      • Dae-Gu, Korea, Republiken av
      • Goyang-Si, Korea, Republiken av
      • Ilsan, Korea, Republiken av
      • Kyounggi, Korea, Republiken av
      • Kyunggi-Do, Korea, Republiken av
      • Seoul, Korea, Republiken av

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • R076477
  • Invega Slow-Release Tablet

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Daytime Drowsiness at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Sleep Quality at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48
Tidsram: Baseline and Week 48
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.
Baseline and Week 48

Samarbetspartners och utredare

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Sponsor

Janssen Korea, Ltd., Korea

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2008

Primärt slutförande (Faktisk)

1 oktober 2010

Avslutad studie (Faktisk)

1 december 2010

Studieregistreringsdatum

Först inskickad

25 september 2008

Först inskickad som uppfyllde QC-kriterierna

26 september 2008

Första postat (Uppskatta)

29 september 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

3 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 maj 2014

Senast verifierad

1 maj 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR015250
  • PAL-KOR-4002

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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