Schizophrenia
Conditions
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.
Interventions
DRUGPaliperidone 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.
Sponsors
Janssen-Cilag International NV
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, France, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed