NCT01734278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

4.3 years

First QC Date

November 22, 2012

Last Update Submit

July 30, 2018

Conditions

Manic Disorder

Outcome Measures

Primary Outcomes (1)

  • The incidence of selected identified risks of asenapine in the mental health care trust setting

    12 weeks after asenapine is first prescribed

Study Arms (1)

Asenapine

Patients prescribed asenapine for any indication.

Other: No intervention

Interventions

No interventionOTHER

This is a non-interventional study.

Asenapine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients prescribed asenapine in a NHS Mental Health Trust in England.

You may qualify if:

  • Patients for whom a study questionnaire containing useful information has been returned

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Staffordshire and Shropshire Healthcare NHS Foundation Trust

Stafford, Staffordshire, ST16 3SR, United Kingdom

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 27, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2017

Study Completion

January 1, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

GB(1)