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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 August 2015 |
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Main ID: |
NCT01926912 |
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Date of registration:
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19/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting
HOSPIPalm |
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Scientific title:
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HOSPItal Use of Paliperidone Palmitate - A Prospective Non-Interventional Study |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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371 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01926912 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Belgium
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Bulgaria
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Denmark
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Germany
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Greece
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Israel
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Kazakhstan
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Russian Federation
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Spain
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Contacts
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Name:
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Janssen-Cilag International NV Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: No intervention
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Primary Outcome(s)
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Number of participants with adverse events
[Time Frame: Up to 6 weeks]
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Number of participants who discontinue the study due to adverse events
[Time Frame: Up to 6 weeks]
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Secondary Outcome(s)
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Clinical Global Impression - Severity (CGI-S) scale score
[Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6]
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Change from baseline in body weight
[Time Frame: Baseline and Week 6]
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Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) score
[Time Frame: Baseline, Week 1, Week 2, Week 5, and Week 6]
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Change from baseline in Personal and Psychosocial functioning (PSP) scale score
[Time Frame: Baseline and Week 6]
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Clinical Global Impression - Change (CGI-C) scale score
[Time Frame: Week 6]
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Subject Satisfaction with previous antipsychotic medication (MSQ) scale score
[Time Frame: Baseline]
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Change from baseline in total Brief Psychiatric Rating Scale (BPRS) score
[Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6]
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Subject Satisfaction with study medication (paliperidone palmitate) scale score
[Time Frame: Week 6]
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Secondary ID(s)
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R092670SCH4017
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CR100862
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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