TREVICTA (paliperidone palmitate 3-monthly)
Research type
Research Study
Full title
Cross-sectional Survey to Collect Treatment Experience Feedback from Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
IRAS ID
252922
Contact name
Sofia Pappa
Contact email
Sponsor organisation
Janssen Pharmaceutical NV
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
The purpose of this observational study is to collect feedback from patients with schizophrenia who have been treated with 4 to 6 injections of Paliperidone palmitate 3 monthly (i.e., approximately 9 to 15 months of PP3M treatment). Feedback will be collected using an online questionnaire-based tool at a single data collection time point. Participation in the study will be entirely be voluntary. Feedback will also be collected from your carer, nurse and treating physician.
An observational study means that the treatment drug Paliperidone Palmitate 3-monthly being studied is already approved for use in Schizophrenia.
The following data will be collected using an online questionnaire and by reviewing your medical records:
• Demographic data and other characteristics (sex, age, height, weight, family status, living arrangement, educational level, occupational/educations activity , smoking habits, alcohol abuse or dependency, psychotropic substance abuse or dependency)
• Disease / medical history (date of diagnosis of schizophrenia, date of first symptoms, date of first antipsychotic treatment administered, psychiatric comorbidities and non-psychiatric comorbidities and severity of your illness)
• Current medication
• Patient experience with PP3M treatment.Each participating site will be provided with the following study-specific materials, where applicable:
Sample participation agreement/ICF
Sample questionnaires for each category of respondent
Hand-held electronic device for use by patients and by carers
Instructions/guidelines to assist in completion of the questionnaires
This study is sponsored by Janssen-Cilag Ltd. This European only study will include
approximately 1200 participants in 8 countries which will include 300 patients, 300 carers, 300 nurses and 300 physicians.REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1826
Date of REC Opinion
15 Nov 2018
REC opinion
Further Information Favourable Opinion