A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting
HOSPIPalm
HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study
2 other identifiers
observational
371
8 countries
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 24, 2015
August 1, 2015
1.3 years
August 19, 2013
August 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with adverse events
Up to 6 weeks
Number of participants who discontinue the study due to adverse events
Up to 6 weeks
Secondary Outcomes (8)
Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score
Baseline, Week 1, Week 2, Week 5, and Week 6
Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Clinical Global Impression - Severity (CGI-S) scale score
Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Clinical Global Impression - Change (CGI-C) scale score
Week 6
Change from baseline in Personal and Psychosocial functioning (PSP) scale score
Baseline and Week 6
- +3 more secondary outcomes
Study Arms (1)
Participants with schizophrenia
Interventions
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.
Eligibility Criteria
Participants with schizophrenia receiving paliperidone palmitate in the hospital setting
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Diest, Belgium
Unknown Facility
Saint-Servais, Belgium
Unknown Facility
Tournai, Belgium
Unknown Facility
Pazardzhik, Bulgaria
Unknown Facility
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
Unknown Facility
Yaroslavl, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2013
First Posted
August 21, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 24, 2015
Record last verified: 2015-08