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

NCT03809325 — Completed, 225 participants, Janssen-Cilag International NV

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

RegistryNCT03809325
StatusCompleted
Study typeObservational
Enrollment225 (Actual)
SponsorJanssen-Cilag International NV (Industry)
ConditionsSchizophrenia
InterventionsPaliperidone Palmitate 3-Month Formulation (PP3M) (Drug)
Datesstart 2018-11-21, primary completion 2019-07-12, completion 2019-07-12, first posted 2019-01-18, last updated 2025-04-27
Locations41 sites in Belgium, France, Germany, Hungary, Italy, Spain, United Kingdom

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Participants with SchizophreniaDrug: 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.
  • Paliperidone Palmitate 3-Month Formulation (PP3M) (Drug), also known as Trevicta: No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.
  • 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.
  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (41)

FacilityCityCountryStatus
Chu BrugmannBrusselsBelgium
Centre Médico Psychologique De CourbevoieAsnières-sur-SeineFrance
Centre Medico PsychologiqueCagnes-sur-MerFrance
Cabinet medicalDaxFrance
Centre Hospitalier EsquirolLimogesFrance
CH de JuryMetzFrance
CH MontaubanMontaubanFrance
Hopital la ColombiereMontpellierFrance
Centre Medico Psychologique Le RembrandtNiceFrance
Centre Hospitalier de NovillarsNovillarsFrance
Centre Hospitalier Guillaume RegnierRennesFrance
Hopital Sainte MusseToulonFrance
Vivantes Klinikum Am UrbanBerlinGermany
NPZR - Neuropsychatrisches Zentrum RiemMünchenGermany
Kbo-Inn-Salzach-Klinikum GmbHWasserburg A. InnGermany
Toldy Ferenc Kórház-RendelőintézetCeglédHungary
Kemenesaljai Egyesített Kórház-Szakorvosi RendelointézetCelldömölkHungary
Sántha Kálmán SzakkórházNagykállóHungary
Tolna Megyei Balassa Janos KorhazSzekszárdHungary
Azienda Sanitaria Alto AdigeBolzanoItaly
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali CiviliBresciaItaly
CSM FrosinoneFrosinoneItaly
Casa di Cura Villa Von SiebenthalGenzano di RomaItaly
Centro Igiene Mentale ASL SalernoOliveto CitraItaly
SPDC AsltarantoStatteItaly
Hosp. Abente E LagoA CoruñaSpain
Csm MirafloresAlcobendasSpain
Csm Arganda Del ReyArgandaSpain
Usmc CarmonaCarmonaSpain
Hosp. Gral. Univ. Gregorio MaranonMadridSpain
Usmc Mairena Del AljarafeMairena del AljarafeSpain
Centre Hosp. de ManresaManresaSpain
Corporacio Sanitari Parc TauliSabadellSpain
Hosp. Univ. de TorreviejaTorreviejaSpain
Hosp. Clinico Univ. de ValenciaValenciaSpain
Csm RondillaValladolidSpain
Hosp. Psiquiatrico AlavaVitoria-GasteizSpain
Hosp. Univ. Miguel ServetZaragozaSpain
Birmingham & Solihull MH NHS FTBirminghamUnited Kingdom
Leicester Partnership NHS TrustLeicesterUnited Kingdom
West London Mental Health TrustLondonUnited Kingdom

+Investigators

  • Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV

My Notes