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

NCT02532842 | Completed

• 2 other identifiers: CR105892R092670SCH4041
• Study Type: observational
• Target: 90
• Locations: 3 countries
• Sites: 7

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone palmitate

Outcome Measures

Primary Outcomes (1)

• Number of Hospitalizations

  12 months

Secondary Outcomes (6)

• Number of Treatment Patterns of paliperidone palmitate as measured by patient records

  12 months

• Treatment response Based on clinical illness, symptom severity and measurements of functioning Score

  12 months

• Parameters of Psychosocial Functioning based on questionnaire

  12 months

• Medical Resource Utilization

  12 months

• Psychiatric hospitalizations preceding the first paliperidone palmitate injection

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Schizophrenia (according to ICD 10 or DSM IV) who were recently diagnosed (\<= 1 year \[y\] before start of PP treatment) with \>= 18 y and \<=29 y of age and who received PP for at least 12 months prior to study start of the study (retrospective cohort).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (7)

Unknown Facility

Rijeka, Croatia

Location

Unknown Facility

Split, Croatia

Location

Unknown Facility

Zagreb, Croatia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Ankara, Turkey (Türkiye)

Location

Unknown Facility

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clinical Trial Janssen Pharmaceutica N.V., Belgium

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 26, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

TU (2); CR (3); RU (2)