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

NCT ID: NCT01926912

Last Updated: 2015-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

371 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with schizophrenia

No intervention

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag International NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

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Diest, , Belgium

Site Status

Saint-Servais, , Belgium

Site Status

Tournai, , Belgium

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Pazardzhik, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Targovishte, , Bulgaria

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Vratsa, , Bulgaria

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Elsinore, , Denmark

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København S, , Denmark

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Berlin, , Germany

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Chemnitz, , Germany

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Dresden, , Germany

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Greifswald, , Germany

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Hamburg, , Germany

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Hennigsdorf, , Germany

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Neuruppin, , Germany

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Pfaffenhofen, , Germany

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Sachsen, , Germany

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Heraklion Crete, , Greece

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Ioannina, , Greece

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Katerini Pieria, , Greece

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Thessaloniki, , Greece

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Bat Yam, , Israel

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Tel Litwinsky, , Israel

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Almaty, , Kazakhstan

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Astana, , Kazakhstan

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Kyzylorda, , Kazakhstan

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Taraz, , Kazakhstan

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Ust-Kamenogorsk, , Kazakhstan

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Chelyabinsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Omsk, , Russia

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Orenburg, Staritsa Village, , Russia

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Saint Petersburg, , Russia

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Tula Region, , Russia

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Yaroslavl, , Russia

Site Status

Countries

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Belgium Bulgaria Denmark Germany Greece Israel Kazakhstan Russia

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3530&filename=CR100862_CSR.pdf

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

Other Identifiers

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R092670SCH4017

Identifier Type: OTHER

Identifier Source: secondary_id

CR100862

Identifier Type: -

Identifier Source: org_study_id

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