Observational Post-Authorisation Safety Study of Asenapine (Sycrest)

Manic Disorder Clinical Trial

— OBSERVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734278
• Other study ID #: OBSERVA
• Status: Completed
• Start date: October 2012
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Drug Safety Research Unit, Southampton, UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Manic Disorder

Intervention

Other:
• No intervention
This is a non-interventional study.

Locations

Country	Name	City	State
United Kingdom	South Staffordshire and Shropshire Healthcare NHS Foundation Trust	Stafford	Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
Professor Saad Shakir	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of selected identified risks of asenapine in the mental health care trust setting		12 weeks after asenapine is first prescribed