NCT01926912

A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting

HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 371 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

Detailed description

This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). This study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). The participant satisfaction will be evaluated at week 6 (or early discontinuation). Safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	No intervention	This is an observational study. Participants prescribed with paliperidone palmitate by the treating physician as per local labeling information in the hospital setting will be observed and data will be collected.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-08-21
• Last updated: 2015-08-24

Locations

39 sites across 8 countries: Belgium, Bulgaria, Denmark, Germany, Greece, Israel, Kazakhstan, Russia