A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
2 other identifiers
observational
225
7 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2018
CompletedFirst Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedApril 27, 2025
April 1, 2025
8 months
January 17, 2019
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Participant's Experience with PP3M Treatment
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 Outcomes (4)
Responses to the Questionnaires
1 day
Clinical Global Impression-Severity (CGI-S) Score
1 day
Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)
1 day
European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score
1 day
Study Arms (1)
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.
Interventions
No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Has received involuntary treatment with PP3M
- Was switched to PP3M treatment within a clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Chu Brugmann
Brussels, 1020, Belgium
Centre Médico Psychologique De Courbevoie
Asnières-sur-Seine, 92600, France
Centre Medico Psychologique
Cagnes-sur-Mer, 6800, France
Cabinet medical
Dax, 40100, France
Centre Hospitalier Esquirol
Limoges, 87025, France
CH de Jury
Metz, 57073, France
CH Montauban
Montauban, 82013, France
Hopital la Colombiere
Montpellier, 34090, France
Centre Medico Psychologique Le Rembrandt
Nice, 6300, France
Centre Hospitalier de Novillars
Novillars, 25220, France
Centre Hospitalier Guillaume Regnier
Rennes, 35703, France
Hopital Sainte Musse
Toulon, 83100, France
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
NPZR - Neuropsychatrisches Zentrum Riem
München, 81829, Germany
Kbo-Inn-Salzach-Klinikum GmbH
Wasserburg A. Inn, 83512, Germany
Toldy Ferenc Kórház-Rendelőintézet
Cegléd, 2700, Hungary
Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet
Celldömölk, 9500, Hungary
Sántha Kálmán Szakkórház
Nagykálló, 4320, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Azienda Sanitaria Alto Adige
Bolzano, 39100, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, 25100, Italy
CSM Frosinone
Frosinone, 3100, Italy
Casa di Cura Villa Von Siebenthal
Genzano di Roma, 100045, Italy
Centro Igiene Mentale ASL Salerno
Oliveto Citra, 84020, Italy
SPDC Asltaranto
Statte, 74010, Italy
Hosp. Abente E Lago
A Coruña, 15006, Spain
Csm Miraflores
Alcobendas, 28100, Spain
Csm Arganda Del Rey
Arganda, 28500, Spain
Usmc Carmona
Carmona, 41410, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28009, Spain
Usmc Mairena Del Aljarafe
Mairena del Aljarafe, 41927, Spain
Centre Hosp. de Manresa
Manresa, 8243, Spain
Corporacio Sanitari Parc Tauli
Sabadell, 8208, Spain
Hosp. Univ. de Torrevieja
Torrevieja, 3188, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Csm Rondilla
Valladolid, 47010, Spain
Hosp. Psiquiatrico Alava
Vitoria-Gasteiz, 1006, Spain
Hosp. Univ. Miguel Servet
Zaragoza, 50009, Spain
Birmingham & Solihull MH NHS FT
Birmingham, B18 5SD, United Kingdom
Leicester Partnership NHS Trust
Leicester, LE2 0TA, United Kingdom
West London Mental Health Trust
London, W3 8NJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2019
First Posted
January 18, 2019
Study Start
November 21, 2018
Primary Completion
July 12, 2019
Study Completion
July 12, 2019
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share