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A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.

19. juni 2014 opdateret af: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized Double-blind Placebo-controlled Parallel Group Study Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Patients With Schizophrenia. Placebo Consists of 20% Intralipid (200 mg/mL) Injectable Emulsion.

The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the safety and tolerability of paliperidone palmitate in patients with stable and symptomatic schizophrenia. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen. Long-acting injectable formulations, such as long-acting injectable paliperidone palmitate, may provide therapeutic plasma concentrations over several weeks, thereby eliminating the need for daily oral medication and making compliance easier. This study is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, parallel-group, multicenter study followed by an open-label extension period in patients with schizophrenia. The study is designed to evaluate the efficacy of paliperidone palmitate (a long-acting injectable formulation) in delaying the time to and decreasing the rate of recurrence compared with placebo in patients with schizophrenia. The study will consist of 5 periods: an up to 7-day screening/washout/tolerability period, a 9-week open-label transition period, a 24-week open-label maintenance period, a randomized, variable-length double-blind, placebo-controlled recurrence prevention period, and an up to 52-week open-label extension period. Patients will have intramuscular (i.m.) study drug injections and efficacy and safety evaluations performed every 4 weeks throughout the study. Efficacy will be evaluated during the study using a recurrence assessment, the Positive and Negative Symptom Scale for Schizophrenia (PANSS), the Clinical Global Impression - Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale. Safety will be assessed throughout the study by monitoring adverse events; use of extrapyramidal symptoms (EPS) rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson Angus Scale [SAS]); clinical laboratory testing; vital signs (temperature, blood pressure, and heart rate) measurements; electrocardiograms (ECGs); and physical examinations. Additionally, the patients will assess the tolerability of the injections by evaluating the pain of the injection and the pain at the injection sites. Tolerability test: 3 mg/day of oral ER OROS paliperidone for 4 days. Transition (9 wks): 50 mg eq. paliperidone palmitate i.m. dose on Day 1, then i.m. injections (25, 50, or 100 mg eq.) once every 4 wks (q4wk). Maintenance (24-wks): paliperidone palmitate i.m. injections (25, 50, or 100 mg eq.) q4wk. Recurrence Prevention: paliperidone palmitate i.m. injections (25, 50, or 100 mg eq. or placebo) q4wk. Open-label paliperidone palmitate (25, 50, 75, or 100 mg eq.) q4wk for 12 dosing periods.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

414

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Costa Rica
      • Costa Rica, Costa Rica
  • Den Russiske Føderation
      • Arkhangelsk, Den Russiske Føderation
      • Moscow, Den Russiske Føderation
      • Moscow N/A, Den Russiske Føderation
      • Moscow Russia, Den Russiske Føderation
      • Samara N/A, Den Russiske Føderation
      • St Petersburg N/A, Den Russiske Føderation
      • Yaroslavl, Den Russiske Føderation
  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
    • California
      • Cerritos, California, Forenede Stater
      • Santa Ana, California, Forenede Stater
    • Florida
      • Hialeah, Florida, Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater
      • Granite City, Illinois, Forenede Stater
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater
      • Shreveport, Louisiana, Forenede Stater
    • Mississippi
      • Flowood, Mississippi, Forenede Stater
    • Missouri
      • St. Louis, Missouri, Forenede Stater
    • New Jersey
      • Clementon, New Jersey, Forenede Stater
    • New York
      • Cedarhurst, New York, Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater
    • Texas
      • Conroe, Texas, Forenede Stater
      • Desoto, Texas, Forenede Stater
      • Irving, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
  • Korea, Republikken
      • Gwangju, Korea, Republikken
      • Inchun, Korea, Republikken
      • Pusan, Korea, Republikken
      • Seoul, Korea, Republikken
  • Mexico
      • Ciudad De Mexico, Mexico
      • Merida, Mexico
      • Monterrey, Mexico
  • Rumænien
      • Bucharest, Rumænien
      • Bucuresti, Rumænien
      • Cluj-Napoca, Rumænien
      • Iasi, Rumænien
      • Sibiu, Rumænien
      • Tg Mures, Rumænien
      • Timisoara, Rumænien
  • Sydafrika
      • Cape Town, Sydafrika
      • Centurion Gauteng, Sydafrika
      • Florida Johannesburg Gauteng, Sydafrika
      • Johannesburg, Sydafrika
  • Taiwan
      • Changhua, Taiwan
      • Kaohsiung, Taiwan
      • Tainan, Taiwan
      • Taoyuan, Taiwan
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Glevakha, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Lvov, Ukraine
      • Odessa, Ukraine
      • Simferopol, Ukraine
      • Vinnitsa, Ukraine

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:

  • Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening
  • have a PANSS score of <120
  • have a body mass index (BMI) >/=15.0 kilogram (kg)/meter (m)2
  • and have resided at the same address for at least 30 days

Exclusion Criteria:

  • Patients unable to provide their own consent
  • have been involuntarily committed to psychiatric hospitalization
  • have primary, active DSM-IV-TM diagnosis other than schizophrenia
  • who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
  • have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications
  • have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water
  • have a history of neuroleptic malignant syndrome (NMS)
  • are at significant risk of suicidal or violent behavior
  • current presence of any significant or unstable medication condition
  • treatment with any protocol disallowed therapies
  • clinically significant result from screening laboratory or ECG.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 001
Paliperidone Palmitate 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
Medicin: Paliperidone Palmitate
25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
Placebo komparator: 002
Placebo Placebo every 4 wk up to 24 mo
Medicin: Placebo
Placebo every 4 wk up to 24 mo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period
Tidsramme: After 68 relapse events
After 68 relapse events

Sekundære resultatmål

Resultatmål
Tidsramme
Changes from randomization to the end of the recurrence prevention period in PANSS (total and subscales), CGI-S, and PSP. Incidence of adverse events, labs and ECGs throughout study.
Tidsramme: After 68 relapse events
After 68 relapse events

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Samarbejdspartnere

Janssen-Cilag International NV

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.

Generelle publikationer

Hjælpsomme links

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. februar 2005

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)

1. februar 2008

Datoer for studieregistrering

Først indsendt

17. maj 2005

Først indsendt, der opfyldte QC-kriterier

17. maj 2005

Først opslået (Skøn)

18. maj 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR004198
  • R092670PSY3001

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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