Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 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 Identifier:
First received: November 22, 2012
Last updated: February 10, 2015
Last verified: February 2015

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: September 2016
Estimated Primary Completion Date: October 2015 (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 identifier: NCT01734278

Contact: Jan Slade 00442380408600

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

No publications provided

Responsible Party: Professor Saad Shakir, Director, Drug Safety Research Unit, Southampton, UK Identifier: NCT01734278     History of Changes
Other Study ID Numbers: OBSERVA
Study First Received: November 22, 2012
Last Updated: February 10, 2015
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on February 27, 2015