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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Drug Safety Research Unit, Southampton, UK
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier:
First received: November 22, 2012
Last updated: January 25, 2016
Last verified: January 2016
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 Intervention
Manic Disorder
Other: No intervention

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Drug Safety Research Unit, Southampton, UK:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients prescribed asenapine for any indication.
Other: No intervention
This is a non-interventional study.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients prescribed asenapine in a NHS Mental Health Trust in England.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734278

Contact: Jan Slade 00442380408600 jan.slade@dsru.org

United Kingdom
South Staffordshire and Shropshire Healthcare NHS Foundation Trust Recruiting
Stafford, Staffordshire, United Kingdom, ST16 3SR
Sponsors and Collaborators
Professor Saad Shakir
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier: NCT01734278     History of Changes
Other Study ID Numbers: OBSERVA 
Study First Received: November 22, 2012
Last Updated: January 25, 2016
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Antipsychotic Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 26, 2016