Manic Disorder
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
This is a non-interventional study.
Sponsors
Merck Sharp & Dohme LLC
Professor Saad Shakir
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of selected identified risks of asenapine in the mental health care trust setting | 12 weeks after asenapine is first prescribed |
Countries
United Kingdom
Outcome results
None listed