A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.
19. juni 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
414
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Costa Rica, Costa Rica
-
-
-
-
-
Arkhangelsk, Den russiske føderasjonen
-
Moscow, Den russiske føderasjonen
-
Moscow N/A, Den russiske føderasjonen
-
Moscow Russia, Den russiske føderasjonen
-
Samara N/A, Den russiske føderasjonen
-
St Petersburg N/A, Den russiske føderasjonen
-
Yaroslavl, Den russiske føderasjonen
-
-
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater
-
-
California
-
Cerritos, California, Forente stater
-
Santa Ana, California, Forente stater
-
-
Florida
-
Hialeah, Florida, Forente stater
-
-
Illinois
-
Chicago, Illinois, Forente stater
-
Granite City, Illinois, Forente stater
-
-
Louisiana
-
Lake Charles, Louisiana, Forente stater
-
Shreveport, Louisiana, Forente stater
-
-
Mississippi
-
Flowood, Mississippi, Forente stater
-
-
Missouri
-
St. Louis, Missouri, Forente stater
-
-
New Jersey
-
Clementon, New Jersey, Forente stater
-
-
New York
-
Cedarhurst, New York, Forente stater
-
-
Ohio
-
Cleveland, Ohio, Forente stater
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater
-
-
Texas
-
Conroe, Texas, Forente stater
-
Desoto, Texas, Forente stater
-
Irving, Texas, Forente stater
-
San Antonio, Texas, Forente stater
-
-
-
-
-
Gwangju, Korea, Republikken
-
Inchun, Korea, Republikken
-
Pusan, Korea, Republikken
-
Seoul, Korea, Republikken
-
-
-
-
-
Ciudad De Mexico, Mexico
-
Merida, Mexico
-
Monterrey, Mexico
-
-
-
-
-
Bucharest, Romania
-
Bucuresti, Romania
-
Cluj-Napoca, Romania
-
Iasi, Romania
-
Sibiu, Romania
-
Tg Mures, Romania
-
Timisoara, Romania
-
-
-
-
-
Cape Town, Sør-Afrika
-
Centurion Gauteng, Sør-Afrika
-
Florida Johannesburg Gauteng, Sør-Afrika
-
Johannesburg, Sør-Afrika
-
-
-
-
-
Changhua, Taiwan
-
Kaohsiung, Taiwan
-
Tainan, Taiwan
-
Taoyuan, Taiwan
-
-
-
-
-
Dnepropetrovsk, Ukraina
-
Glevakha, Ukraina
-
Kharkiv, Ukraina
-
Kiev, Ukraina
-
Kyiv, Ukraina
-
Lvov, Ukraina
-
Odessa, Ukraina
-
Simferopol, 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 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 001
Paliperidone Palmitate 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
|
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
|
Placebo every 4 wk up to 24 mo
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
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
- Ceraso A, Lin JJ, Schneider-Thoma J, Siafis S, Tardy M, Komossa K, Heres S, Kissling W, Davis JM, Leucht S. Maintenance treatment with antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2020 Aug 11;8(8):CD008016. doi: 10.1002/14651858.CD008016.pub3.
- Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
- Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.
- Emsley R, Nuamah I, Gopal S, Hough D, Fleischhacker WW. Relapse After Antipsychotic Discontinuation in Schizophrenia as a Withdrawal Phenomenon vs Illness Recurrence: A Post Hoc Analysis of a Randomized Placebo-Controlled Study. J Clin Psychiatry. 2018 Jun 19;79(4):17m11874. doi: 10.4088/JCP.17m11874.
- Kozma CM, Slaton T, Dirani R, Fastenau J, Gopal S, Hough D. Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE). Curr Med Res Opin. 2011 Aug;27(8):1603-11. doi: 10.1185/03007995.2011.595000. Epub 2011 Jun 22.
- Hough D, Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010 Feb;116(2-3):107-17. doi: 10.1016/j.schres.2009.10.026. Epub 2009 Dec 2.
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. februar 2005
Primær fullføring (Faktiske)
1. februar 2007
Studiet fullført (Faktiske)
1. februar 2008
Datoer for studieregistrering
Først innsendt
17. mai 2005
Først innsendt som oppfylte QC-kriteriene
17. mai 2005
Først lagt ut (Anslag)
18. mai 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. juni 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Patologiske prosesser
- Sykdomsattributter
- Schizofrenispektrum og andre psykotiske lidelser
- Schizofreni
- Tilbakefall
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Dopaminmidler
- Serotonin 5-HT2-reseptorantagonister
- Serotonin-antagonister
- Dopamin D2-reseptorantagonister
- Dopaminantagonister
- Paliperidonpalmitat
Andre studie-ID-numre
- CR004198
- R092670PSY3001
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. .