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

Schizophrenia Clinical Trial

Official title:

Paliperidone Palmitate in Early Schizophrenia - A Retrospective, Non-interventional Study of Patients With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate Over a 12-Month Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532842
• Other study ID #: CR105892
• Secondary ID: R092670SCH4041
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2015
• Last updated: November 2, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: The Ministry of Education and Science of the Russian Federation
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Countries where clinical trial is conducted

Croatia,  Russian Federation,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hospitalizations		12 months	No
Secondary	Number of Treatment Patterns of paliperidone palmitate as measured by patient records		12 months	No
Secondary	Treatment response Based on clinical illness, symptom severity and measurements of functioning Score		12 months	No
Secondary	Parameters of Psychosocial Functioning based on questionnaire		12 months	No
Secondary	Medical Resource Utilization		12 months	No
Secondary	Psychiatric hospitalizations preceding the first paliperidone palmitate injection		12 months	No
Secondary	Number of Participants with Adverse Events		12 months	Yes