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Completed

NCT Number: NCT01734278

Observational Post-Authorisation Safety Study of Asenapine (Sycrest)

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.

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Key information

Conditions

Manic Disorder Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South Staffordshire and Shropshire Healthcare NHS Foundation Trust

Stafford, Staffordshire, ST16 3SR, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. The incidence of selected identified risks of asenapine in the mental health care trust setting

    Time frame: 12 weeks after asenapine is first prescribed

Sponsors and collaborators

Lead sponsor

Professor Saad Shakir

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: OBSERVA

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Nov 27, 2012
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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