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Trial record 9 of 3310 for:    schizophrenia

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 (PsiProsper)

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ClinicalTrials.gov Identifier: NCT03666715
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Farmaceutica Ltda.

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.

Condition or disease Intervention/treatment
Schizophrenia Drug: Oral Antipsychotics (OAPs) Drug: Paliperidone Palmitate 1-Month Formulation (PP1M)

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Study Type : Observational
Estimated Enrollment : 107 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : August 7, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Drug: 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: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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 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.

  2. 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 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.

  3. 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 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.

  4. 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 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.

  5. Mean Length of Hospitalizations [ Time Frame: Approximately 24 months ]
    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.

  6. Mean Change in Length of Hospitalizations Between Periods [ Time Frame: Approximately 24 months ]
    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.

  7. Mean Cumulative Length of Hospitalizations [ Time Frame: Approximately 24 months ]
    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.

  8. Mean Change in Cumulative Length of Hospitalizations Between Periods [ Time Frame: Approximately 24 months ]
    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.

  9. Hospitalization Rate per Patient-Years [ Time Frame: Approximately 24 months ]
    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.

  10. Mean Number of Emergency Psychiatric Visits [ Time Frame: Approximately 24 months ]
    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.

  11. Mean Change in Emergency Psychiatric Visits Between Periods [ Time Frame: Approximately 24 months ]
    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.

  12. Percentage of Participants Hospitalized [ Time Frame: Approximately 24 months ]
    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.

  13. Change in Percentages of Participants Hospitalized Between Periods (Hospitalization Reduction Percentage) [ Time Frame: Approximately 24 months ]
    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.

  14. Percentage of Outpatient Psychiatric Consultations [ Time Frame: Approximately 24 months ]
    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.

  15. Change in Percentage of Outpatient Psychiatric Consultations Between Periods [ Time Frame: Approximately 24 months ]
    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.

  16. Percentage of Relapse with Different Causes [ Time Frame: Approximately 24 months ]
    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.

  17. Change in Percentages of Relapse Between Periods with Different Causes [ Time Frame: Approximately 24 months ]
    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.

  18. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666715


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Portugal
Neurobios , Instituto De Neurociências Recruiting
Porto, Portugal, Portugal, 4200 - 117
Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
Investigators
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Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.

Additional Information:
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Responsible Party: Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier: NCT03666715     History of Changes
Other Study ID Numbers: CR108528
R092670SCH4063 ( Other Identifier: Janssen-Cilag Farmaceutica Ltda. )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Paliperidone Palmitate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents