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

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)

• Registration Number: NCT03809325
• Lead Sponsor: Janssen-Cilag International NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-21
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Schizophrenia	Paliperidone Palmitate 3-Month Formulation (PP3M)	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.

Primary Outcome Measures

Name	Time	Method
Participant's Experience with PP3M Treatment	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.

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)	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.
Responses to the Questionnaires	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.
Clinical Global Impression-Severity (CGI-S) Score	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.
European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score	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.

Trial Locations

Locations (41)

Birmingham & Solihull MH NHS FT; 🇬🇧 Birmingham, United Kingdom

Leicester Partnership NHS Trust; 🇬🇧 Leicester, United Kingdom

West London Mental Health Trust; 🇬🇧 London, United Kingdom

Csm Arganda Del Rey; 🇪🇸 Arganda, Spain

Usmc Carmona; 🇪🇸 Carmona, Spain

Hosp. Gral. Univ. Gregorio Maranon; 🇪🇸 Madrid, Spain

Usmc Mairena Del Aljarafe; 🇪🇸 Mairena Del Aljarafe, Spain

Centre Hosp. de Manresa; 🇪🇸 Manresa, Spain

Corporacio Sanitari Parc Tauli; 🇪🇸 Sabadell, Spain

Hosp. Univ. de Torrevieja; 🇪🇸 Torrevieja, Spain

Hosp. Clinico Univ. de Valencia; 🇪🇸 Valencia, Spain

Csm Rondilla; 🇪🇸 Valladolid, Spain

Hosp. Psiquiatrico Alava; 🇪🇸 Vitoria-Gasteiz, Spain

Hosp. Univ. Miguel Servet; 🇪🇸 Zaragoza, Spain

Centro Igiene Mentale ASL Salerno; 🇮🇹 Oliveto Citra, Italy

SPDC Asltaranto; 🇮🇹 Statte, Italy

Hosp. Abente E Lago; 🇪🇸 A Coruña, Spain

Csm Miraflores; 🇪🇸 Alcobendas, Spain

Hopital la Colombiere; 🇫🇷 Montpellier, France

Hopital Sainte Musse; 🇫🇷 Toulon, France

Tolna Megyei Balassa Janos Korhaz; 🇭🇺 Szekszárd, Hungary

Chu Brugmann; 🇧🇪 Bruxelles, Belgium

Centre Médico Psychologique De Courbevoie; 🇫🇷 Asnieres Sur Seine, France

Centre Medico Psychologique; 🇫🇷 Cagnes Sur Mer, France

Cabinet medical; 🇫🇷 Dax, France

Centre Hospitalier Esquirol; 🇫🇷 Limoges, France

CH de Jury; 🇫🇷 Metz Cedex 3, France

CH Montauban; 🇫🇷 Montauban, France

Centre Medico Psychologique Le Rembrandt; 🇫🇷 Nice, France

Centre Hospitalier de Novillars; 🇫🇷 Novillars, France

Centre Hospitalier Guillaume Regnier; 🇫🇷 Rennes Cedex 7, France

Vivantes Klinikum Am Urban; 🇩🇪 Berlin, Germany

NPZR - Neuropsychatrisches Zentrum Riem; 🇩🇪 Muenchen, Germany

Kbo-Inn-Salzach-Klinikum GmbH; 🇩🇪 Wasserburg A. Inn, Germany

Toldy Ferenc Kórház-Rendelőintézet; 🇭🇺 Cegléd, Hungary

Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet; 🇭🇺 Celldömölk, Hungary

Sántha Kálmán Szakkórház; 🇭🇺 Nagykálló, Hungary

Azienda Sanitaria Alto Adige; 🇮🇹 Bolzano, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili; 🇮🇹 Brescia, Italy

CSM Frosinone; 🇮🇹 Frosinone, Italy

Casa di Cura Villa Von Siebenthal; 🇮🇹 Genzano di Roma, Italy