Clinical trial NCT03666715: 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
Official title: A Multicenter Retrospective Study to Analyse the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Patients With Schizophrenia in Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Janssen-Cilag Farmaceutica Ltda.
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include ambulatory participants diagnosed with schizophrenia that switched from oral antipsychotics (OAPs) to paliperidone palmitate 1-month formulation (PP1M), and with available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment
timeFrame: Approximately 12 months
measure: Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months After Initiation of PP1M Treatment
timeFrame: Approximately 12 months
measure: Mean Change of Schizophrenia-Related Hospital Admissions Between Periods
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Mean Number of Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M and During 12 Months After Initiation of PP1M Treatment for the Subgroup of Participants that Completed 12 Months of PP1M Treatment
timeFrame: Approximately 24 months
measure: Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants that Completed 12 Months of PP1M Treatment
timeFrame: Approximately 24 months
measure: Mean Number of Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M and During 12 Months After Initiation of PP1M Treatment for the Subgroup of Participants that Discontinued Before Completing 12 Months of PP1M Treatment
timeFrame: Approximately 24 months
measure: Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants That Discontinued Before Completing 12 Months of PP1M Treatment
timeFrame: Approximately 24 months
measure: Mean Length of Hospitalizations
timeFrame: Approximately 24 months
measure: Mean Change in Length of Hospitalizations Between Periods
timeFrame: Approximately 24 months
measure: Mean Cumulative Length of Hospitalizations
timeFrame: Approximately 24 months
measure: Mean Change in Cumulative Length of Hospitalizations Between Periods
timeFrame: Approximately 24 months
measure: Hospitalization Rate per Patient-Years
timeFrame: Approximately 24 months
measure: Mean Number of Emergency Psychiatric Visits
timeFrame: Approximately 24 months
measure: Mean Change in Emergency Psychiatric Visits Between Periods
timeFrame: Approximately 24 months
measure: Percentage of Participants Hospitalized
timeFrame: Approximately 24 months
measure: Change in Percentages of Participants Hospitalized Between Periods (Hospitalization Reduction Percentage)
timeFrame: Approximately 24 months
measure: Percentage of Outpatient Psychiatric Consultations
timeFrame: Approximately 24 months
measure: Change in Percentage of Outpatient Psychiatric Consultations Between Periods
timeFrame: Approximately 24 months
measure: Percentage of Relapse with Different Causes
timeFrame: Approximately 24 months
measure: Change in Percentages of Relapse Between Periods with Different Causes
timeFrame: Approximately 24 months
measure: Percentage of Participants who Discontinued PP1M Treatment with Different Reasons for Discontinuation Before and After Completing 12 Months of Treatment
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Neurobios , Instituto De Neurociências
Study officials:
affiliation: Janssen-Cilag Farmaceutica Ltda.
name: Janssen-Cilag Farmaceutica Ltda. Clinical Trial
role: STUDY_DIRECTOR
References: