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

Sponsor

Professor Saad Shakir (Other)

Overall Status

Completed

CT.gov ID

NCT01734278

Collaborator

Merck Sharp & Dohme LLC (Industry)

1,000

Enrollment

Location

Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Manic Disorder	Other: No intervention

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Asenapine Patients prescribed asenapine for any indication.	Other: No intervention This is a non-interventional study.

Arm

Intervention/Treatment

Asenapine

Patients prescribed asenapine for any indication.

Other: No intervention

This is a non-interventional study.

Outcome Measures

Primary Outcome Measures

The incidence of selected identified risks of asenapine in the mental health care trust setting [12 weeks after asenapine is first prescribed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Staffordshire and Shropshire Healthcare NHS Foundation Trust	Stafford	Staffordshire	United Kingdom	ST16 3SR

Sponsors and Collaborators

Professor Saad Shakir
Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK

ClinicalTrials.gov Identifier:

NCT01734278

Other Study ID Numbers:

OBSERVA

First Posted:

Nov 27, 2012

Last Update Posted:

Jul 31, 2018

Last Verified:

Jul 1, 2018

Additional relevant MeSH terms:

Bipolar Disorder

Study Results

No Results Posted as of Jul 31, 2018