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Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate

17. september 2014 oppdatert av: Janssen-Cilag Farmaceutica Ltda.

Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study

The purpose of this study is to explore the efficacy of paliperidone palmitate administered as a once monthly injection in patients with an acute exacerbation of schizophrenia.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is an open-label (patients and study staff will know the identity of treatments assigned) study of paliperidone palmitate in patients with acute an exacerbation of schizophrenia. The total duration of the study will be approximately 4 months. Eligible patients without a documented history of exposure to oral risperidone or paliperidone extended-release (ER), or intramuscular (IM) RISPERDAL CONSTA or paliperidone palmitate will receive oral risperidone 1 mg/day or extended release (ER) OROS paliperidone 3 mg/day for at least 3 days before the first injection of the study drug (paliperidone palmitate) for tolerability testing. Paliperidone palmitate will be administered to patients as an intramuscular (IM) injection in the deltoid (upper arm) or gluteal (buttocks) muscle.

Studietype

Intervensjonell

Registrering (Faktiske)

142

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Brasil
      • Porto Alegre, Brasil
      • Riberao Preto, Brasil
      • Sao Jose, Brasil
      • Sao Paulo, Brasil
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bucarmanga, Colombia
      • Medellin, Colombia
  • Mexico
      • Acapulco, Mexico
      • Guadalajara, Mexico
      • Mexico, Mexico
      • Monterrey, Mexico

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 49 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Be otherwise healthy on the basis of physical examination and vital signs at Screening (Baseline) and have a current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening and no longer than 5 years (early diagnosed patients)
  • Have acute exacerbation of psychosis defined as: less than 4 weeks but more than 4 days, PANSS total score of 70 to 120 (inclusive) at screening (moderate symptomatology), a score of 4 or more (at least moderately ill) at screening on the severity scale of the CGI-S
  • If a woman, before entry she must be postmenopausal for at least 1 year, surgically sterile or abstinent. If sexually active, agree to practice an effective method of birth control before entry and throughout the study as specified in the protocol; If a man is heterosexually active with a woman of childbearing potential, he must agree to use a double-barrier method of birth control and to not donate sperm during the study and for 50 days after receiving the last dose of the study drug

Exclusion Criteria:

  • Has evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in the past 6 months (as determined by medical history, clinical laboratory or electrocardiogram [ECG] results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study
  • The psychiatric diagnosis is due to direct pharmacological effects of a substance (eg, a drug of abuse or medication) or a general medical condition (eg, clinically notable hypothyroidism, delirium)
  • Meets the DSM-IV definition of substance dependence (except for nicotine and caffeine) within 6 months prior to entry
  • Has history or current symptoms of tardive dyskinesia (involuntary repetitive body movements)
  • Has history of neuroleptic malignant syndrome

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: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Paliperidonpalmitat
Legemiddel: Paliperidone palmitate
Type=exact number, unit=mg, number=150, 100, 75 mg equivalent (eq), form=suspension for injection, route=intramuscular use. One IM injection of 150 mq on Day 1, 100 mg eq. on Day 8 (+/- 4 days), and 75 mg eq. is recommended on Days 36, 64, and 92.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in the Positive and Negative Syndrome Scale (PANSS)
Tidsramme: Baseline to 4 months
The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS, which 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 question is rated on a scale of 1 (absent) to 7 (extreme).
Baseline to 4 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in global severity of illness using the clinical global impression - severity (CGI-S) scores
Tidsramme: Baseline to 4 months
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, the patient will be assessed on severity of mental illness at the time of rating between 1 (not ill) and 7 (extremely severe).
Baseline to 4 months
Change from Baseline in the personal and social performance scale (PSP)
Tidsramme: Baseline to 4 months
The PSP scale assesses the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior:(a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. A score between 71 and 100 indicates only mild difficulties, and one between 31 and 70 indicates varying degrees of disability. A patient with a score of 30 or less has functioning so poor he or she requires intensive support or supervision..
Baseline to 4 months

Samarbeidspartnere og etterforskere

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

Sponsor

Janssen-Cilag Farmaceutica Ltda.

Etterforskere

  • Studieleder: Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Hjelpsomme linker

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. september 2011

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

6. september 2011

Først innsendt som oppfylte QC-kriteriene

6. oktober 2011

Først lagt ut (Anslag)

7. oktober 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. september 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2014

Sist bekreftet

1. september 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR017977
  • R092670SCH3012 (Annen identifikator: Janssen-Cilag Farmaceutica Ltda.)

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