Observational Post-Authorisation Safety Study of Asenapine (Sycrest)
NCT ID: NCT01734278
Last Updated: 2018-07-31
Study Results
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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COMPLETED
1000 participants
OBSERVATIONAL
2012-10-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asenapine
Patients prescribed asenapine for any indication.
No intervention
This is a non-interventional study.
Interventions
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No intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients within selected institutions (for example prisons)
* Patients who commenced treatment between date of market launch (to be confirmed) and study start
* Enrolled patients for whom both the baseline and 12-week questionnaires are returned blank (contain no clinical information)
* Enrolled patients for whom the psychiatrist, designated member of clinical care team, or study facilitator from the DSRU reports that the patient did not take or was never prescribed asenapine
* Enrolled patients for whom there is evidence to suggest duplication of patients
* Enrolled patients for whom informed written or verbal notification is received by DSRU indicating that they no longer wish to participate at any stage of the study
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Professor Saad Shakir
OTHER
Responsible Party
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Professor Saad Shakir
Director
Locations
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South Staffordshire and Shropshire Healthcare NHS Foundation Trust
Stafford, Staffordshire, United Kingdom
Countries
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Other Identifiers
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OBSERVA
Identifier Type: -
Identifier Source: org_study_id
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