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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809325
• Other study ID #: CR108568
• Secondary ID: R092670SCH4066
• Status: Completed
• Start date: November 21, 2018
• Est. completion date: July 12, 2019

Study information

• Verified date: July 2019
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Belgium	Chu Brugmann	Bruxelles
France	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	Hôpital La Colombière	Montpellier
France	Centre Medico Psychologique Le Rembrandt	Nice
France	Centre Hospitalier de Novillars	Novillars
France	Centre Hospitalier Guillaume Regnier	Rennes Cedex 7
France	Hôpital Sainte Musse	Toulon
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	NPZR - Neuropsychatrisches Zentrum Riem	Muenchen
Germany	Kbo-Inn-Salzach-Klinikum GmbH	Wasserburg A. Inn
Hungary	Toldy Ferenc Kórház-Rendelointézet	Cegléd
Hungary	Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet	Celldömölk
Hungary	Sántha Kálmán Szakkórház	Nagykálló
Hungary	Tolna Megyei Balassa János Kórház	Szekszárd
Italy	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	Centro Igiene Mentale ASL Salerno	Oliveto Citra
Italy	SPDC Asltaranto	Statte
Spain	Hosp. Abente E Lago	A Coruña
Spain	Csm Miraflores	Alcobendas
Spain	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
United Kingdom	Birmingham & Solihull MH NHS FT	Birmingham
United Kingdom	Leicester Partnership NHS Trust	Leicester
United Kingdom	West London Mental Health Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Responses to the Questionnaires	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
Secondary	Clinical Global Impression-Severity (CGI-S) Score	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
Secondary	Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)	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
Secondary	European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score	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

External Links

•   To learn how to participate in this trial please click here.