SchizophreniaPsiProsperNCT03666715
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
An observational study of Schizophrenia, run by Janssen-Cilag Farmaceutica Ltda. at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oral Antipsychotics (OAPs) and Paliperidone Palmitate 1-Month Formulation (PP1M)
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Aug 2018to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Schizophrenia
- Being tested
- Oral Antipsychotics (OAPs), Paliperidone Palmitate 1-Month Formulation (PP1M)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Antipsychotics (OAPs)Drug
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)Drug
No study treatment will be administered as a part of this study. Participants will receive PP1M as per their usual clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oral Antipsychotics (OAPs); Drug: Paliperidone Palmitate 1-Month Formulation (PP1M) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment
Mean number of schizophrenia-related hospital admissions occurred during 12 months of oral antipsychotics (OAP) treatment prior to initiation of Paliperidone Palmitate 1-Month Formulation (PP1M) treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Measured: Approximately 12 months
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months After Initiation of PP1M Treatment
Mean number of schizophrenia-related hospital admissions occurred during 12 months after initiation of PP1M treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Measured: Approximately 12 months
Mean Change of Schizophrenia-Related Hospital Admissions Between Periods
Mean change of schizophrenia-related hospital admissions occurred between periods (during 12 months of OAP treatment prior and 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Secondary outcomes (18)
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
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 will be reported. Mean number of hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Measured: Approximately 24 months
Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants that Completed 12 Months of PP1M Treatment
Mean change of hospital admissions occurred for the subgroup of participants that completed 12 months of PP1M between periods (during 12 months of OAP treatment prior and after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
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
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 will be reported. Mean number of hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Measured: Approximately 24 months
Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants That Discontinued Before Completing 12 Months of PP1M Treatment
Mean change of hospital admissions occurred for the subgroup of participants that discontinued before completing 12 months of PP1M treatment between periods (during 12 months of OAP treatment prior and after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Mean Length of Hospitalizations
Mean length of hospitalizations occurred during 12 months after initiation of OAP treatment and the mean length of hospitalizations occurred during 12 months after initiation of PP1M treatment will be reported.
Measured: Approximately 24 months
Mean Change in Length of Hospitalizations Between Periods
Mean change in length of hospitalizations between periods (occurred during 12 months after initiation of OAP treatment and during 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Mean Cumulative Length of Hospitalizations
The mean cumulative length of hospitalizations occurred during 12 months after initiation of OAP treatment and the mean length of hospitalizations occurred during 12 months after initiation of PP1M treatment will be reported.
Measured: Approximately 24 months
Mean Change in Cumulative Length of Hospitalizations Between Periods
Mean change in cumulative length of hospitalizations between periods (occurred during 12 months after initiation of OAP treatment and during 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Hospitalization Rate per Patient-Years
The hospitalization rate per patient-year will be calculated as: Hospitalization rate per patient-years = Number of hospitalizations in the treatment period divided by total follow-up time in the treatment period where the total follow-up time corresponds to the cumulative follow-up time of all included participants in the treatment period.
Measured: Approximately 24 months
Mean Number of Emergency Psychiatric Visits
The mean number of emergency psychiatric visits occurred during 12 months of OAP treatment prior to PP1M and the mean number of emergency psychiatric visits occurred during 12 months after initiation of PP1M treatment will be reported.
Measured: Approximately 24 months
Mean Change in Emergency Psychiatric Visits Between Periods
Mean change in emergency psychiatric visits between periods (occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Percentage of Participants Hospitalized
Percentage of participants hospitalized during 12 months of OAP treatment prior to PP1M and the percentage of participants hospitalized during 12 months after initiation of PP1M treatment will be reported.
Measured: Approximately 24 months
Change in Percentages of Participants Hospitalized Between Periods (Hospitalization Reduction Percentage)
Change in percentage of participants hospitalized between periods (percentage of participants hospitalized during 12 months of OAP treatment prior to PP1M and the percentage of participants hospitalized during 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Percentage of Outpatient Psychiatric Consultations
Percentage of outpatient psychiatric consultations occurred during 12 months of OAP treatment prior to PP1M and the percentage of outpatient psychiatric consultations occurred during 12 months after initiation of PP1M treatment will be reported.
Measured: Approximately 24 months
Change in Percentage of Outpatient Psychiatric Consultations Between Periods
Change in percentage of outpatient psychiatric consultations between periods (occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Percentage of Relapse with Different Causes
Percentage of relapse with different causes occurred during 12 months of OAP treatment prior to PP1M and the percentage of relapse occurred during 12 months after initiation of PP1M treatment will be reported.
Measured: Approximately 24 months
Change in Percentages of Relapse Between Periods with Different Causes
Change in percentage of relapse between periods with different causes (occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment) will be reported.
Measured: Approximately 24 months
Percentage of Participants who Discontinued PP1M Treatment with Different Reasons for Discontinuation Before and After Completing 12 Months of Treatment
Percentage of participants who discontinued PP1M treatment with different reasons for discontinuation (such as, lack of efficacy, tolerability issues or other) before and after completing 12 months of treatment will be reported.
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start7 Aug 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Farmaceutica Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Farmaceutica Ltda. Clinical Trial, Study director, Janssen-Cilag Farmaceutica Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666715
- Sponsor's protocol ID
- CR108528
- Other IDs
- R092670SCH4063
- Acronym
- PsiProsper
- Status last verified
- Apr 2025
- First submitted
- 10 Sep 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03666715
- Acronym / sponsor ID
- PsiProsper / CR108528
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Janssen-Cilag Farmaceutica Ltda.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Schizophrenia | – | Drug: Oral Antipsychotics (OAPs), Drug: Paliperidone Palmitate 1-Month Formulation (PP1M)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Participants with Schizophrenia |
| 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. | Drug | Participants with Schizophrenia |
Primary outcome
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment
Time frame: Approximately 12 months
Mean number of schizophrenia-related hospital admissions occurred during 12 months of oral antipsychotics (OAP) treatment prior to initiation of Paliperidone Palmitate 1-Month Formulation (PP1M) treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months After Initiation of PP1M Treatment
Time frame: Approximately 12 months
Mean number of schizophrenia-related hospital admissions occurred during 12 months after initiation of PP1M treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants.
Mean Change of Schizophrenia-Related Hospital Admissions Between Periods
Time frame: Approximately 24 months
Mean change of schizophrenia-related hospital admissions occurred between periods (during 12 months of OAP treatment prior and 12 months after initiation of PP1M treatment) will be reported.
18 secondary outcomes
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
Time frame: Approximately 24 months
Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants that Completed 12 Months of PP1M Treatment
Time frame: Approximately 24 months
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
Time frame: Approximately 24 months
Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants That Discontinued Before Completing 12 Months of PP1M Treatment
Time frame: Approximately 24 months
Mean Length of Hospitalizations
Time frame: Approximately 24 months
Mean Change in Length of Hospitalizations Between Periods
Time frame: Approximately 24 months
Mean Cumulative Length of Hospitalizations
Time frame: Approximately 24 months
Mean Change in Cumulative Length of Hospitalizations Between Periods
Time frame: Approximately 24 months
Hospitalization Rate per Patient-Years
Time frame: Approximately 24 months
Mean Number of Emergency Psychiatric Visits
Time frame: Approximately 24 months
Mean Change in Emergency Psychiatric Visits Between Periods
Time frame: Approximately 24 months
Percentage of Participants Hospitalized
Time frame: Approximately 24 months
Change in Percentages of Participants Hospitalized Between Periods (Hospitalization Reduction Percentage)
Time frame: Approximately 24 months
Percentage of Outpatient Psychiatric Consultations
Time frame: Approximately 24 months
Change in Percentage of Outpatient Psychiatric Consultations Between Periods
Time frame: Approximately 24 months
Percentage of Relapse with Different Causes
Time frame: Approximately 24 months
Change in Percentages of Relapse Between Periods with Different Causes
Time frame: Approximately 24 months
Percentage of Participants who Discontinued PP1M Treatment with Different Reasons for Discontinuation Before and After Completing 12 Months of Treatment
Time frame: Approximately 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Farmaceutica Ltda. Clinical Trial study director
Janssen-Cilag Farmaceutica Ltda.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag Farmaceutica Ltda. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment (time frame: Approximately 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.