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:
Professor Saad Shakir
Collaborator:
Merck
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
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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:
MedlinePlus related topics:
Mental Health
Drug Information available for:
Asenapine
U.S. FDA Resources
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
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 May 16, 2013