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

NCT ID: NCT02532842

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-09-30

Brief 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.

Detailed 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.

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Participants with Schizophrenia

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Janssen Pharmaceutica N.V., Belgium

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

Rijeka, , Croatia

Split, , Croatia

Zagreb, , Croatia

Moscow, , Russia

Saint Petersburg, , Russia

Ankara, , Turkey (Türkiye)

Denizli, , Turkey (Türkiye)

Countries

Croatia; Russia; Turkey (Türkiye)

Other Identifiers

R092670SCH4041

Identifier Type: OTHER

Identifier Source: secondary_id

CR105892

Identifier Type: -

Identifier Source: org_study_id