A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    64
  • sponsor
    Janssen-Cilag Farmaceutica Ltda.
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Updated on 26 January 2021
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Summary

The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone Palmitate 1-month formulation treatment.

Details
Condition Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), schizophrenia disorders
Treatment Oral Antipsychotics (OAPs), Paliperidone Palmitate 1-Month Formulation (PP1M)
Clinical Study IdentifierNCT03666715
SponsorJanssen-Cilag Farmaceutica Ltda.
Last Modified on26 January 2021

Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 55 yrs?
Gender: Male or Female
Do you have any of these conditions: Schizophrenia or Schizophrenia and Schizoaffective Disorders or Schizophrenia and Schizoaffective Disorders (Pediatric)?
Do you have any of these conditions: Schizophrenia and Schizoaffective Disorders or Schizophrenia and Schizoaffective Disorders (Pediatric) or schizophrenia disorders or Schizophrenia?
Do you have any of these conditions: schizophrenia disorders or Schizophrenia and Schizoaffective Disorders (Pediatric) or Schizophrenia and Schizoaffective Disorders or Schizophrenia?
Do you have any of these conditions: Schizophrenia and Schizoaffective Disorders or Schizophrenia or schizophrenia disorders or Schizophrenia and Schizoaffective Disorders (Pediatric)?
Must have a confirmed diagnosis schizophrenia according to the International Classification of Diseases (ICD) 9th Edition codes, or the correspondent ICD-10 codes if applicable
Must have been treated with oral antipsychotics (OAPs) and who switched to paliperidone palmitate 1-month formulation (PP1M) due to poor adherence, or lack of efficacy (no significant symptom reduction, as judged by the treating physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants' choice, or unknown reason when the switch has not been clearly justified
Had been treated with OAPs for at least 12 months prior to switching to PP1M. During the treatment with OAPs, dose adjustments were allowed. Participants should have been treated with PP1M for at least 4 consecutive months after the switch
Must have available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment during the observation period, and with the indication of PP1M initiation in their medical charts
Must be being treated at an ambulatory setting at study entry

Exclusion Criteria

Participants with schizophrenia resistant to treatment (TR). TR is defined for the purpose of this study by at least two failed adequate trials with different antipsychotics (at maximal antipsychotic efficacious label dose for 4 to 6 consecutive weeks)
Participants that used clozapine as treatment for schizophrenia in any given period prior to or during the observation period, independently of other concomitant psychotropic medication
Participants who have participated in a clinical trial during the observation period
Participants that switched to PP1M before the 31st of July 2014, that is in the first 6 months after it was available for reimbursement in Portugal
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