Non-Interventional Study of Participants With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate
2 november 2015 uppdaterad av: Janssen Pharmaceutica N.V., Belgium
Paliperidone Palmitate in Early Schizophrenia - A Retrospective, Non-interventional Study of Patients With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate Over a 12-Month Period
The primary objective of this study is to explore hospitalization (number, length and reasons for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants during the first 12 months of treatment with once monthly paliperidone palmitate in naturalistic clinical settings.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate.
Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected.
The study will be conducted in countries within the EMEA region in which paliperidone palmitate is approved and available.
The study will be considered complete with the last data collection for the last participant participating in the study.
Studietyp
Observationell
Inskrivning (Faktisk)
90
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ankara, Kalkon
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Denizli, Kalkon
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Rijeka, Kroatien
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Split, Kroatien
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Zagreb, Kroatien
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Moscow, Ryska Federationen
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St Petersburg N/A, Ryska Federationen
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St-Petersburg, Ryska Federationen
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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 29 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Participants with Schizophrenia (according to ICD 10 or DSM IV) who were recently diagnosed (<= 1 year [y] before start of PP treatment) with >= 18 y and <=29 y of age and who received PP for at least 12 months prior to study start of the study (retrospective cohort).
Beskrivning
Inclusion Criteria:
- Participant must be a man or woman aged at least 18 years but not more than 29 years at the time of the first injection of paliperidone palmitate
- Participant must have a documented diagnosis of schizophrenia according to either Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD 10) or Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM 4)
- Participant's first psychotic episode suggestive of schizophrenia must have been clinically evident not longer than 1 year prior to the first injection of paliperidone palmitate
- Participant must have documentation (medical records) of at least 12 months (365 +/- 31 days) continuous treatment with paliperidone palmitate administered for the first time as part of clinical practice. This documentation must have been completed in the participant's records before the initiation of the study site
- Participant must have initiated paliperidone palmitate treatment after the launch date (ie, commercial availability) of paliperidone palmitate at his/her respective site
Exclusion Criteria:
- Participant has either an ICD 10 or DSM 4 axis I diagnosis other than schizophrenia
- Participant was diagnosed with alcohol or drug dependence (except for nicotine and caffeine dependence) according to either ICD 10 or DSM 4 criteria within 1 month prior to initiation of paliperidone palmitate treatment or during the 12 month documentation period
- Participant was treated with any long acting injectable antipsychotic prior to paliperidone palmitate initiation or with a long-acting injectable antipsychotic other than paliperidone palmitate during the 12 month documentation period
- Participant received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days prior to paliperidone palmitate initiation or during the 12 month documentation period
- Participant participated in an interventional or a non-interventional clinical study during the 12 month documentation period
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Participants with Schizophrenia
This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate.
Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Antal sjukhusvistelser
Tidsram: 12 månader
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12 månader
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Number of Treatment Patterns of paliperidone palmitate as measured by patient records
Tidsram: 12 months
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12 months
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Treatment response Based on clinical illness, symptom severity and measurements of functioning Score
Tidsram: 12 months
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12 months
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Parameters of Psychosocial Functioning based on questionnaire
Tidsram: 12 months
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12 months
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Medical Resource Utilization
Tidsram: 12 months
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12 months
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Psychiatric hospitalizations preceding the first paliperidone palmitate injection
Tidsram: 12 months
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12 months
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Number of Participants with Adverse Events
Tidsram: 12 months
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12 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Clinical Trial Janssen Pharmaceutica N.V., Belgium, Janssen Pharmaceutica N.V., Belgium
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 juli 2015
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
1 september 2015
Studieregistreringsdatum
Först inskickad
4 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
21 augusti 2015
Första postat (Uppskatta)
26 augusti 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
3 november 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2015
Senast verifierad
1 november 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR105892
- R092670SCH4041 (Annan identifierare: Janssen Pharmaceutica NV)
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