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

July 30, 2018 updated by: Professor Saad Shakir

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Staffordshire
      • Stafford, Staffordshire, United Kingdom, ST16 3SR
        • South Staffordshire and Shropshire Healthcare NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients prescribed asenapine in a NHS Mental Health Trust in England.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of selected identified risks of asenapine in the mental health care trust setting
Time Frame: 12 weeks after asenapine is first prescribed
12 weeks after asenapine is first prescribed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Saad Shakir

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 27, 2012

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBSERVA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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