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A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

2. mai 2016 oppdatert av: Janssen Research & Development, LLC

A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Studietype

Intervensjonell

Registrering (Faktiske)

509

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Medellin, Colombia
      • Pereira, Colombia
  • Forente stater
    • Arkansas
      • Little Rock, Arkansas, Forente stater
    • California
      • San Fran Cisco, California, Forente stater
    • District of Columbia
      • Washington, District of Columbia, Forente stater
    • Florida
      • Lauderhill, Florida, Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater
      • Hoffman Estates, Illinois, Forente stater
    • Kansas
      • Topeka, Kansas, Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater
    • Mississippi
      • Flowood, Mississippi, Forente stater
    • New Jersey
      • Marlton, New Jersey, Forente stater
    • New York
      • Cedarhurst, New York, Forente stater
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
    • Texas
      • Austin, Texas, Forente stater
      • Dallas, Texas, Forente stater
    • Utah
      • Salt Lake City, Utah, Forente stater
  • Korea, Republikken
      • Deajun, Korea, Republikken
      • Gyeongsangnam-Do, Korea, Republikken
      • Incheon, Korea, Republikken
      • Seongnam, Korea, Republikken
  • Malaysia
      • Johor Bahru, Malaysia
      • Kuala Lumpur, Malaysia
      • Tanjong Rambutan, Malaysia
  • Mexico
      • Guadajalara, Mexico
      • Mexico City, Mexico
      • Monterrey, Mexico
      • San Luis Potosi, Mexico
      • Zapopan, Mexico
  • Romania
      • Arad, Romania
      • Craiova, Romania
      • Iasi, Romania
      • Sibiu, Romania
      • Tg Mures, Romania
  • Tyrkia
      • Diyarbakir, Tyrkia
      • Sakarya, Tyrkia
  • Ukraina
      • Donetsk, Ukraina
      • Evpatoriya, Ukraina
      • Glevakha, Ukraina
      • Ivano-Frankivsk, Ukraina
      • Kerch, Ukraina
      • Kharkiv, Ukraina
      • Kharkov, Ukraina
      • Kherson, Ukraina
      • Kiev, Ukraina
      • Lviv, Ukraina
      • Lvov, Ukraina
      • Odesa, Ukraina
      • Odessa, Ukraina
      • Poltava, Ukraina
      • Smela, Ukraina
      • Ternopil, Ukraina
      • Uzhgorod, Ukraina
      • Vinnitsa, Ukraina

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with schizophrenia for more than 1 year
  • A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
  • Signed informed consent
  • Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
  • Men must agree to use a double-barrier method of birth control
  • Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
  • A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
  • Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
  • A diagnosis of substance dependence within 6 months before screening
  • History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
  • Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
  • Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
  • Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo (20% Intralipid emulsion)
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Eksperimentell: Paliperidone palmitate 3-month (PP3M)
Legemiddel: PP3M 175 mg eq.
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Legemiddel: PP3M 263 mg eq.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Legemiddel: PP3M 350 mg eq.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Legemiddel: PP3M 525 mg eq.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Relapse During the Double-Blind Phase
Tidsramme: Approximately Week 60
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
Approximately Week 60

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Tidsramme: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Tidsramme: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Tidsramme: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Research & Development, LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2012

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. april 2014

Datoer for studieregistrering

Først innsendt

6. februar 2012

Først innsendt som oppfylte QC-kriteriene

8. februar 2012

Først lagt ut (Anslag)

9. februar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. mai 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2016

Sist bekreftet

1. mai 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR100717
  • R092670PSY3012 (Annen identifikator: Janssen Research & Development, LLC)
  • 2011-004676-11 (EudraCT-nummer)
  • U1111-1135-1969 (Annen identifikator: Universal Trial Number)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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