Clinical trial NCT03809325: A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Official title: Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Participant's Experience with PP3M Treatment
timeFrame: 1 day
Secondary outcomes:
measure: Responses to the Questionnaires
timeFrame: 1 day
measure: Clinical Global Impression-Severity (CGI-S) Score
timeFrame: 1 day
measure: Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)
timeFrame: 1 day
measure: European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score
timeFrame: 1 day
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Chu Brugmann
city: Asnieres Sur Seine
country: France
facility: Centre Médico Psychologique De Courbevoie
city: Cagnes Sur Mer
country: France
facility: Centre Medico Psychologique
city: Dax
country: France
facility: Cabinet medical
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
city: Metz Cedex 3
country: France
facility: CH de Jury
city: Montauban
country: France
facility: CH Montauban
city: Montpellier
country: France
facility: Hopital la Colombiere
city: Nice
country: France
facility: Centre Medico Psychologique Le Rembrandt
city: Novillars
country: France
facility: Centre Hospitalier de Novillars
city: Rennes Cedex 7
country: France
facility: Centre Hospitalier Guillaume Regnier
city: Toulon
country: France
facility: Hopital Sainte Musse
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Muenchen
country: Germany
facility: NPZR - Neuropsychatrisches Zentrum Riem
city: Wasserburg A. Inn
country: Germany
facility: Kbo-Inn-Salzach-Klinikum GmbH
city: Cegléd
country: Hungary
facility: Toldy Ferenc Kórház-Rendelőintézet
city: Celldömölk
country: Hungary
facility: Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet
city: Nagykálló
country: Hungary
facility: Sántha Kálmán Szakkórház
city: Szekszárd
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz
city: Bolzano
country: Italy
facility: Azienda Sanitaria Alto Adige
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
city: Frosinone
country: Italy
facility: CSM Frosinone
city: Genzano di Roma
country: Italy
facility: Casa di Cura Villa Von Siebenthal
city: Oliveto Citra
country: Italy
facility: Centro Igiene Mentale ASL Salerno
city: Statte
country: Italy
facility: SPDC Asltaranto
city: A Coruña
country: Spain
facility: Hosp. Abente E Lago
city: Alcobendas
country: Spain
facility: Csm Miraflores
city: Arganda
country: Spain
facility: Csm Arganda Del Rey
city: Carmona
country: Spain
facility: Usmc Carmona
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Mairena Del Aljarafe
country: Spain
facility: Usmc Mairena Del Aljarafe
city: Manresa
country: Spain
facility: Centre Hosp. de Manresa
city: Sabadell
country: Spain
facility: Corporacio Sanitari Parc Tauli
city: Torrevieja
country: Spain
facility: Hosp. Univ. de Torrevieja
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Valladolid
country: Spain
facility: Csm Rondilla
city: Vitoria-Gasteiz
country: Spain
facility: Hosp. Psiquiatrico Alava
city: Zaragoza
country: Spain
facility: Hosp. Univ. Miguel Servet
city: Birmingham
country: United Kingdom
facility: Birmingham & Solihull MH NHS FT
city: Leicester
country: United Kingdom
facility: Leicester Partnership NHS Trust
city: London
country: United Kingdom
facility: West London Mental Health Trust
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: