Manic DisorderOBSERVANCT01734278
Observational Post-Authorisation Safety Study of Asenapine (Sycrest)
An observational study of Manic Disorder, run by Professor Saad Shakir at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Manic Disorder
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients prescribed asenapine in a NHS Mental Health Trust in England.
Who may be able to join
- Patients for whom a study questionnaire containing useful information has been returned
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South Staffordshire and Shropshire Healthcare NHS Foundation Trust
Stafford, Staffordshire, ST16 3SR
About this study
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
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.
- Conditions
- Manic Disorder
- Being tested
- No intervention
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Patients prescribed asenapine for any indication. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of selected identified risks of asenapine in the mental health care trust setting
Measured: 12 weeks after asenapine is first prescribed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Saad Shakir
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Professor Saad Shakir, Drug Safety Research Unit, Southampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734278
- Sponsor's protocol ID
- OBSERVA
- Acronym
- OBSERVA
- Status last verified
- Jul 2018
- First submitted
- 22 Nov 2012
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01734278
- Acronym / sponsor ID
- OBSERVA / OBSERVA
- Conditions
- Manic Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Professor Saad ShakirUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asenapine | – | Other: No interventionPatients prescribed asenapine for any indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients prescribed asenapine in a NHS Mental Health Trust in England.
Key inclusion criteria (1 listed)
- Patients for whom a study questionnaire containing useful information has been returned
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a non-interventional study. | Other | Asenapine |
Primary outcome
The incidence of selected identified risks of asenapine in the mental health care trust setting
Time frame: 12 weeks after asenapine is first prescribed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Manic Disorder, run by Professor Saad Shakir at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of selected identified risks of asenapine in the mental health care trust setting (time frame: 12 weeks after asenapine is first prescribed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.