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Completed

NCT Number: NCT03809325

A 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brugmann, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paliperidone Palmitate 3-Month Formulation (PP3M)

Drug

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

Primary outcomes

  1. Participant's Experience with PP3M Treatment

    Time frame: 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

  1. Responses to the Questionnaires

    Time frame: 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.

  2. Clinical Global Impression-Severity (CGI-S) Score

    Time frame: 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.

  3. Positive and Negative Syndrome Scale (PANSS) - Lack of Judgement and Insight's Score (G12 Item)

    Time frame: 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.

  4. European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ 5D-5L) Questionnaire General Health Status Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag International NV

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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