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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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19 February 2015 |
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Main ID: |
NCT00696813 |
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Date of registration:
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05/06/2008 |
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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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Observational Study to Assess Outcomes During Antipsychotic Treatment With Paliperidone ER or Other Oral Antipsychotics
PILAR |
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Scientific title:
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PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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3064 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00696813 |
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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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Canada
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Czech Republic
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Denmark
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Kazakhstan
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Sweden
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Thailand
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Ukraine
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Contacts
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Name:
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Janssen Pharmaceutica N.V. 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 Pharmaceutica N.V. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of schizophrenia
- Switch to or start on paliperidone ER or another oral antipsychotic treatment (either
atypical or conventional), not longer than 2 weeks ago
- Signed informed consent is available at the beginning of documentation
- Able and willing to fill-out self-administered questionnaires
Exclusion Criteria:
- Established treatment-refractory schizophrenia
- History of neuroleptic malignant syndrome
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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Primary Outcome(s)
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Primary treatment duration and time to treatment discontinuation
[Time Frame: Prospective 1-year observation period]
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Secondary Outcome(s)
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Deterioration of the psychotic condition
[Time Frame: at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation]
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Use of concomitant medications
[Time Frame: during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation]
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The prospectively documented treatment outcomes also include overall severity of symptoms, personal and social performance, healthcare utilization and health related quality of life and quality of sleep.
[Time Frame: 12 months]
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Secondary ID(s)
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CR014707
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R076477SCH4016
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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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