A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

April 25, 2025 updated by: Janssen-Cilag International NV

Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1020
        • CHU Brugmann
  • France
      • Asnieres Sur Seine, France, 92600
        • Centre Médico Psychologique De Courbevoie
      • Cagnes Sur Mer, France, 6800
        • Centre Medico Psychologique
      • Dax, France, 40100
        • Cabinet Medical
      • Limoges, France, 87025
        • Centre Hospitalier Esquirol
      • Metz Cedex 3, France, 57073
        • CH de Jury
      • Montauban, France, 82013
        • CH Montauban
      • Montpellier, France, 34090
        • Hôpital La Colombière
      • Nice, France, 6300
        • Centre Medico Psychologique Le Rembrandt
      • Novillars, France, 25220
        • Centre Hospitalier de Novillars
      • Rennes Cedex 7, France, 35703
        • Centre Hospitalier Guillaume Régnier
      • Toulon, France, 83100
        • Hôpital Sainte Musse
  • Germany
      • Berlin, Germany, 10967
        • Vivantes Klinikum Am Urban
      • Muenchen, Germany, 81829
        • NPZR - Neuropsychatrisches Zentrum Riem
      • Wasserburg A. Inn, Germany, 83512
        • Kbo-Inn-Salzach-Klinikum GmbH
  • Hungary
      • Cegléd, Hungary, 2700
        • Toldy Ferenc Kórház-Rendelőintézet
      • Celldömölk, Hungary, 9500
        • Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet
      • Nagykálló, Hungary, 4320
        • Sántha Kálmán Szakkórház
      • Szekszárd, Hungary, 7100
        • Tolna Megyei Balassa János Kórház
  • Italy
      • Bolzano, Italy, 39100
        • Azienda Sanitaria Alto Adige
      • Brescia, Italy, 25100
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
      • Frosinone, Italy, 3100
        • CSM Frosinone
      • Genzano di Roma, Italy, 100045
        • Casa di Cura Villa Von Siebenthal
      • Oliveto Citra, Italy, 84020
        • Centro Igiene Mentale ASL Salerno
      • Statte, Italy, 74010
        • SPDC Asltaranto
  • Spain
      • A Coruña, Spain, 15006
        • Hosp. Abente E Lago
      • Alcobendas, Spain, 28100
        • Csm Miraflores
      • Arganda, Spain, 28500
        • Csm Arganda Del Rey
      • Carmona, Spain, 41410
        • Usmc Carmona
      • Madrid, Spain, 28009
        • Hosp. Gral. Univ. Gregorio Maranon
      • Mairena Del Aljarafe, Spain, 41927
        • Usmc Mairena Del Aljarafe
      • Manresa, Spain, 8243
        • Centre Hosp. de Manresa
      • Sabadell, Spain, 8208
        • Corporacio Sanitari Parc Tauli
      • Torrevieja, Spain, 3188
        • Hosp. Univ. de Torrevieja
      • Valencia, Spain, 46010
        • Hosp. Clinico Univ. de Valencia
      • Valladolid, Spain, 47010
        • Csm Rondilla
      • Vitoria-Gasteiz, Spain, 1006
        • Hosp. Psiquiatrico Alava
      • Zaragoza, Spain, 50009
        • Hosp. Univ. Miguel Servet
  • United Kingdom
      • Birmingham, United Kingdom, B18 5SD
        • Birmingham & Solihull MH NHS FT
      • Leicester, United Kingdom, LE2 0TA
        • Leicester Partnership NHS Trust
      • London, United Kingdom, W3 8NJ
        • West London Mental Health Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants diagnosed with schizophrenia who are currently receiving paliperidone palmitate 3-month formulation (PP3M) and have previously received 4 to 6 injections of PP3M treatment will be enrolled. Feedback will be collected using an online questionnaire-based tool at a single data collection time point.

Description

Inclusion Criteria:

  • Have a diagnosis of schizophrenia (according to International Classification of Diseases [ICD]-10)
  • Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
  • Have the required language skills to participate in the online questionnaire, in the opinion of the physician
  • Be able and willing to provide their informed consent for study participation

Exclusion Criteria:

  • Has received involuntary treatment with PP3M
  • Was switched to PP3M treatment within a clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with Schizophrenia
No intervention will be administered as a part of this study. Participants diagnosed with schizophrenia, who have been treated with 4 to 6 injections of paliperidone palmitate 3-month formulation (PP3M), together with the corresponding physician, and the corresponding nurse and carer where applicable for each participant will be enrolled in this survey. The data source for this study will be the online questionnaire used for each participant, physician, and the corresponding nurse and carer where applicable.
Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)
No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
Other Names:
  • Trevicta

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant's Experience with PP3M Treatment
Time Frame: 1 day
Participant's experience with paliperidone palmitate 3-month formulation (PP3M) treatment will be evaluated qualitatively through an online questionnaire. Each questionnaire will include a total of approximately 30 to 35 multiple choice questions related to following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responses to the Questionnaires
Time Frame: 1 day
The response to the questionnaires of the corresponding physician, and the corresponding nurse and carer where applicable, for each participant will be collected for the following categories: Impact on relationship/ interaction between medical team and carer/ patient, Involvement in treatment decision, Reasons for PP3M, Impact of treatment on patient, Impact of treatment on carer and General experience with PP3M.
1 day
Clinical Global Impression-Severity (CGI-S) Score
Time Frame: 1 day
The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. The CGI-S permits a global evaluation of the participant's condition at a given time.
1 day
Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)
Time Frame: 1 day
The PANSS is a validated scale specific for the measurement of the symptoms of schizophrenia. The neuropsychiatric symptoms of schizophrenia are assessed across 3 subscales comprising a total of 30 items; the positive [P] and negative [N] subscales each includes 7 items, while the general psychopathology [G] subscale includes 16 items. Lack of judgment and insight's score is 12th item of the general psychopathology subscale (G12 item) of PANSS with score ranges from 1 to 7. Higher scores indicate worsening.
1 day
European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score
Time Frame: 1 day
EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The responses to the 5 dimensions are used to compute a single utility score ranging from zero (worst health state) to 1 (better health state) representing the general health status of the individual.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag International NV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag International NV Clinical Trial, Janssen-Cilag International NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108568
  • R092670SCH4066 (Other Identifier: Janssen-Cilag International NV)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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