Clinical trial NCT02532842: Non-Interventional Study of Participants With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone palmitate
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Number of Hospitalizations
timeFrame: 12 months
Secondary outcomes:
measure: Number of Treatment Patterns of paliperidone palmitate as measured by patient records
timeFrame: 12 months
measure: Treatment response Based on clinical illness, symptom severity and measurements of functioning Score
timeFrame: 12 months
measure: Parameters of Psychosocial Functioning based on questionnaire
timeFrame: 12 months
measure: Medical Resource Utilization
timeFrame: 12 months
measure: Psychiatric hospitalizations preceding the first paliperidone palmitate injection
timeFrame: 12 months
measure: Number of Participants with Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Rijeka
country: Croatia
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Moscow
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Ankara
country: Turkey
city: Denizli
country: Turkey
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Clinical Trial Janssen Pharmaceutica N.V., Belgium
role: STUDY_DIRECTOR
References: