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

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: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone Palmitate 3-Month Formulation (PP3M)

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

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 Médical
  • 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 Regnier
  • 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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Janssen-Cilag International NV

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 21, 2018
• Primary Completion (ACTUAL): July 12, 2019
• Study Completion (ACTUAL): July 12, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR108568; R092670SCH4066 (OTHER: 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