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Completed

NCT Number: NCT01765127

An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)

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.

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Key information

Conditions

Bipolar I Disorder

Sex eligibility

All sexes

Study type

Observational

Primary location

Drug Safety Research Unit (for data collation and analysis only)

Southampton, Hampshire, SO31 1AA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Professor Saad Shakir

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jan 10, 2013
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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