Non-Interventional Study of Participants With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Schizophrenia

Study type: Observational

Funder types: Industry

Identifiers

NCT02532842

CR105892

R092670SCH4041 (Other Identifier)

Details and patient eligibility

About

The primary objective of this study is to explore hospitalization (number, length and reasons for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants during the first 12 months of treatment with once monthly paliperidone palmitate in naturalistic clinical settings.

Full description

This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate. Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected. The study will be conducted in countries within the EMEA region in which paliperidone palmitate is approved and available. The study will be considered complete with the last data collection for the last participant participating in the study.

Enrollment: 90 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be a man or woman aged at least 18 years but not more than 29 years at the time of the first injection of paliperidone palmitate
• Participant must have a documented diagnosis of schizophrenia according to either Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD 10) or Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM 4)
• Participant's first psychotic episode suggestive of schizophrenia must have been clinically evident not longer than 1 year prior to the first injection of paliperidone palmitate
• Participant must have documentation (medical records) of at least 12 months (365 +/- 31 days) continuous treatment with paliperidone palmitate administered for the first time as part of clinical practice. This documentation must have been completed in the participant's records before the initiation of the study site
• Participant must have initiated paliperidone palmitate treatment after the launch date (ie, commercial availability) of paliperidone palmitate at his/her respective site

Exclusion criteria

• Participant has either an ICD 10 or DSM 4 axis I diagnosis other than schizophrenia
• Participant was diagnosed with alcohol or drug dependence (except for nicotine and caffeine dependence) according to either ICD 10 or DSM 4 criteria within 1 month prior to initiation of paliperidone palmitate treatment or during the 12 month documentation period
• Participant was treated with any long acting injectable antipsychotic prior to paliperidone palmitate initiation or with a long-acting injectable antipsychotic other than paliperidone palmitate during the 12 month documentation period
• Participant received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days prior to paliperidone palmitate initiation or during the 12 month documentation period
• Participant participated in an interventional or a non-interventional clinical study during the 12 month documentation period

Trial design

90 participants in 1 patient group

Participants with Schizophrenia

Description:

This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate. Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected.