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An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest) | Clinical Trials | Clareo Health

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

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

NCT01765127•Professor Saad Shakir

View on ClinicalTrials.gov

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 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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (1)

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

Southampton, Hampshire, United Kingdom

Key Dates

Start Date

January 1, 2012

Primary Completion Date

February 1, 2017

Completion Date

January 1, 2018

Last Updated

July 31, 2018

Enrollment

122

ACTUAL participants

Conditions

Bipolar I Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

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ERG Components in Schizophrenia and Bipolar Disorder Type I

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