Bipolar I DisorderNCT01765127
An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)
An observational study of Bipolar I Disorder, run by Professor Saad Shakir at 1 site in United Kingdom.
Trial summary
This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar I Disorder
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients prescribed asenapine for any indication by NHS GPs in England.
Who may be able to join
- Patients prescribed asenapine for any indication by NHS GPs in England.
- Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.
Who cannot join
- patient no longer registered with the practice
- patient for whom no information is provided on study questionnaire
- patients for whom information provided on study questionnaire relates to another antipsychotic drug
- patients for whom the index date is an improbable date (i.e. before market launch date)
- patients for whom the GP reports that the patient did not take or was never prescribed asenapine
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Drug Safety Research Unit (for data collation and analysis only)
Southampton, Hampshire, SO31 1AA
About this study
Official title: An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study to Monitor the Safety and Utilization of Asenapine (Sycrest) in the Primary Care Setting in England
This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.
- Conditions
- Bipolar I Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of selected important identified and potential risks
Incidence rates of these risks will be quantified:
- Somnolence and sedation
- Weight gain
- Oral hypoaesthesia
- Swelling of the tongue and throat
- Allergic reactions (Type 1 hypersensitivity)
Measured: At least 3 months after drug 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 posted10 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 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 Bipolar I 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
- Retrospective
- Enrolment
- 122 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
- Investigators
- Saad Shakir, Professor, Principal investigator, Drug Safety Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765127
- Sponsor's protocol ID
- Asenapine ModPEM
- Status last verified
- Jul 2018
- First submitted
- 18 Dec 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-Authorization Modified Prescription-Event Monitoring Safety Study to Monitor the Safety and Utilization of Asenapine (Sycrest) in the Primary Care Setting in England
- ClinicalTrials.gov ID
- NCT01765127
- Acronym / sponsor ID
- Asenapine ModPEM
- Conditions
- Bipolar I Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Professor Saad ShakirUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2012
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 10 Jan 2013 (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.
This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asenapine | – | –Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients prescribed asenapine for any indication by NHS GPs in England.
Key inclusion criteria (2 listed)
- Patients prescribed asenapine for any indication by NHS GPs in England.
- Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.
Key exclusion criteria (5 listed)
- patient no longer registered with the practice
- patient for whom no information is provided on study questionnaire
- patients for whom information provided on study questionnaire relates to another antipsychotic drug
- patients for whom the index date is an improbable date (i.e. before market launch date)
- patients for whom the GP 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.
Primary outcome
Incidence rate of selected important identified and potential risks
Time frame: At least 3 months after drug is first prescribed.
Incidence rates of these risks will be quantified: * Somnolence and sedation * Weight gain * Oral hypoaesthesia * Swelling of the tongue and throat * Allergic reactions (Type 1 hypersensitivity)
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.
Saad Shakir, Professor principal investigator
Drug Safety Research Unit
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 Bipolar I 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 2 inclusion and 5 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?
Incidence rate of selected important identified and potential risks (time frame: At least 3 months after drug 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.