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
NCT ID: NCT03666715
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2018-08-07
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants with Schizophrenia
Participants diagnosed with schizophrenia who switched from oral antipsychotics (OAPs) to Paliperidone Palmitate 1-month formulation (PP1M), with available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment, and who switched to PP1M at least 6-months after it was available for reimbursement in Portugal will be observed. The primary data source for this study will be the medical records of each participant.
Oral Antipsychotics (OAPs)
No study treatment will be administered as a part of this study. Participants will receive OAPs (such as olanzapine, risperidone, paliperidone, aripiprazole or quetiapine) as per their usual clinical practice.
Paliperidone Palmitate 1-Month Formulation (PP1M)
No study treatment will be administered as a part of this study. Participants will receive PP1M as per their usual clinical practice.
Interventions
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Oral Antipsychotics (OAPs)
No study treatment will be administered as a part of this study. Participants will receive OAPs (such as olanzapine, risperidone, paliperidone, aripiprazole or quetiapine) as per their usual clinical practice.
Paliperidone Palmitate 1-Month Formulation (PP1M)
No study treatment will be administered as a part of this study. Participants will receive PP1M as per their usual clinical practice.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
No
Sponsors
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Janssen-Cilag Farmaceutica Ltda.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen-Cilag Farmaceutica Ltda. Clinical Trial
Role: STUDY_DIRECTOR
Janssen-Cilag Farmaceutica Ltda.
Locations
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Neurobios , Instituto De Neurociências
Porto, , Portugal
Countries
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Other Identifiers
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R092670SCH4063
Identifier Type: OTHER
Identifier Source: secondary_id
CR108528
Identifier Type: -
Identifier Source: org_study_id
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