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

This study is currently recruiting participants.
Verified January 2013 by Drug Safety Research Unit, Southampton, UK
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
ClinicalTrials.gov Identifier:
NCT01734278
First received: November 22, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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
Patients Prescribed Asenapine for Moderate to Severe Manic Episodes Associated With Bipolar I Disorder in Adults (or Off-label Use).
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: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Asenapine
Patients prescribed asenapine for any indication.
Other: No intervention
This is a non-interventional study.

  Eligibility

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.

Criteria

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

Contacts
Contact: Felicity Mitchell, PhD 00442380019562 felicity.mitchell@dsru.org

Locations
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
ClinicalTrials.gov Identifier: NCT01734278     History of Changes
Other Study ID Numbers: OBSERVA
Study First Received: November 22, 2012
Last Updated: January 8, 2013
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014