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

Schizophrenia Clinical Trial

— HOSPIPalm  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926912
• Other study ID #: CR100862
• Secondary ID: R092670SCH4017
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2013
• Last updated: August 21, 2015
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2015
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityRussia: Ministry of Health of the Russian FederationBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesGreece: Ethics CommitteeIsrael: Ministry of HealthSpain: Spanish Agency of MedicinesNorway: Norwegian Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants diagnosed with schizophrenia

• Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity

• Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital

Exclusion Criteria:

• Participant has a known hypersensitivity to paliperidone or risperidone

• Participant has previously been treated with paliperidone palmitate

• Participant has a history of neuroleptic malignant syndrome

• Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Denmark,  Germany,  Greece,  Israel,  Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Up to 6 weeks	Yes
Primary	Number of participants who discontinue the study due to adverse events		Up to 6 weeks	Yes
Secondary	Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score	The ESRS is a 12 item clinician-rated scale designed to assess the severety of extrapyramidal symptoms. Dyskinesic movements are rated according to bothfrequency and amplitude. It measures the four types of drug-induced movement disorders. (Parkinsonism, Dystonia, akathisia, and Dyskinesia). Items are rated on a 7-point scale ranging from 0 (normal) to 6 (extremely severe). The higher the score, the more severely the symptoms affect function. Higher scores indicate worsening.	Baseline, Week 1, Week 2, Week 5, and Week 6	Yes
Secondary	Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score	The BPRS is used for the measurement of psychiatric symptoms. The BPRS is an 18 item questionnaire and each question is rated on a 7 point scale ranging from 1 (not present) to 7 (extremely severe). The total score for the 18 question will be calculated by adding score of each question. The interpretation of the total scores are: 0-9 will indicate "not a schizoaffective case"; 10-20 will indicate "possible schizoaffective case"; and 21 or more, will indicate "evident schizoaffective case". Higher scores indicate worsening.	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6	No
Secondary	Clinical Global Impression - Severity (CGI-S) scale score	The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.	Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6	No
Secondary	Clinical Global Impression - Change (CGI-C) scale score	The CGI-C is a 7-point assessment scale of change in global clinical status, defined as a sense of well-being and ability to function in daily activities. CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Higher scores indicate worsening.	Week 6	No
Secondary	Change from baseline in Personal and Psychosocial functioning (PSP) scale score	The PSP is used as a measure of personal and social functioning of participants with psychiatric disorders. The PSP scale assesses the degree of difficulty a participant exhibits over a 1-month period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior and provide rating from 1 to 100. Participants with score of 71 to 100 have a mild degree of difficulty; from 31 to 70 have marked difficulty and from 1 to 30, have represent severe degrees of difficulty. Lower scores indicate worsening.	Baseline and Week 6	No
Secondary	Subject Satisfaction with previous antipsychotic medication (MSQ) scale score	Treatment satisfaction with previous anti psychiatric medication among participants with schizophrenia will be assessed by using the MSQ scale. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. Lower scores indicate worsening.	Baseline	No
Secondary	Subject Satisfaction with study medication (paliperidone palmitate) scale score	Treatment satisfaction with study medication (paliperidone palmitate) among participants with schizophrenia will be assessed by using the MSQ scale. It consists of 1 question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied. Lower scores indicate worsening.	Week 6	No
Secondary	Change from baseline in body weight		Baseline and Week 6	Yes

External Links

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