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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01734278
Recruitment Status : Active, not recruiting
First Posted : November 27, 2012
Last Update Posted : October 28, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Manic Disorder Other: No intervention

Study Design

Study Type : Observational
Actual Enrollment : 1000 participants
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
Study Start Date : October 2012
Primary Completion Date : September 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Asenapine
Patients prescribed asenapine for any indication.
Other: No intervention
This is a non-interventional study.


Outcome Measures

Primary Outcome Measures :
  1. The incidence of selected identified risks of asenapine in the mental health care trust setting [ Time Frame: 12 weeks after asenapine is first prescribed ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734278


Locations
United Kingdom
South Staffordshire and Shropshire Healthcare NHS Foundation Trust
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
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs