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Completed

NCT Number: NCT02532842

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

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijeka, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Hospitalizations

    Time frame: 12 months

Secondary outcomes

  1. Number of Treatment Patterns of paliperidone palmitate as measured by patient records

    Time frame: 12 months

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

    Time frame: 12 months

  3. Parameters of Psychosocial Functioning based on questionnaire

    Time frame: 12 months

  4. Medical Resource Utilization

    Time frame: 12 months

  5. Psychiatric hospitalizations preceding the first paliperidone palmitate injection

    Time frame: 12 months

  6. Number of Participants with Adverse Events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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