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Observational Post-Authorisation Safety Study of Asenapine (Sycrest) (OBSERVA)

This study is currently recruiting participants.
Verified January 2013 by Drug Safety Research Unit, Southampton, UK
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier:
NCT01734278
First received: November 22, 2012
Last updated: January 8, 2013
Last verified: January 2013
History of Changes

November 22, 2012
January 8, 2013
October 2012
October 2014   (final data collection date for primary outcome measure)
The incidence of selected identified risks of asenapine in the mental health care trust setting [ Time Frame: 12 weeks after asenapine is first prescribed ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01734278 on ClinicalTrials.gov Archive Site
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Observational Post-Authorisation Safety Study of Asenapine (Sycrest)
An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England

The purpose of this observational study is to evaluate the use and short term safety of Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the manufacturer of Sycrest.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients prescribed asenapine in a NHS Mental Health Trust in England.
Patients Prescribed Asenapine for Moderate to Severe Manic Episodes Associated With Bipolar I Disorder in Adults (or Off-label Use).
Other: No intervention
This is a non-interventional study.
Asenapine
Patients prescribed asenapine for any indication.
Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients for whom a study questionnaire containing useful information has been returned

Exclusion Criteria:

  • Patients who do not provide consent
  • 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
Both
18 Years and older
No
Contact: Felicity Mitchell, PhD 00442380019562 felicity.mitchell@dsru.org
United Kingdom
 
NCT01734278
OBSERVA
No
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
Professor Saad Shakir
Merck
Not Provided
Drug Safety Research Unit, Southampton, UK
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP