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Project Summary

Background

There is insufficient data available about safety of using many medications in children and adolescents who may have an illness that itself predispose them to suicidality. There is also insufficient data available about the time-course of medication related suicidality and what happens to it over the long-term. Further, there is insufficient data available about the long-term safety, in particular about medication related suicidality, especially since there is evidence to suggest that paediatric populations may represent a vulnerable group compared to adults.

The STOP project arises from the collaboration of a group of experts in paediatric psychopharmacology within the framework of the European Child and Adolescent Paediatric Network (ECAPN). ECAPN is supported by the European College of Neuropsychopharmacology (ECNP) (www.ecnp.eu) and its network initiative (EcnpNI).

Objectives

The STOP project aims to develop a comprehensive web-based methodology for the assessment and monitoring of suicidality in children and adolescents. Four domains are of importance for this purpose: assessment and monitoring of suicidality, assessment of putative risk and protective factors but also mediators (intermediate outcomes contributing to treatment effects), assessment of psychiatric and physical symptoms and medication characteristics.

This assessment methodology will be used in three clinical samples to identify characteristic features of medication-related suicidality (MRS): children and adolescent receiving an atypical antipsychotic, children receiving fluoxetine for depression and children treated with montelukast for bronchial asthma. These medications were targeted because they have been related to suicidality.

Summary of the STOP project

The project consists of 12 Workpackages (WPs).
WP1 covers the management of the overall project.
WPs 2 to 4 are each focusing on specific aspects of the bio-psycho-social mediators of suicidality. WP2 consists in a meta-analysis looking for medication-related suicidality signals in an international database. WP3 establishes the biological sampling methodology for investigation of mediators of suicidality and WP4 focuses on the psychosocial mediators of suicidality.
WP5 focuses on the assessment of suicidality. WP6 converts the assessment of suicidality and the bio-psycho-social mediators of suicidality (including specific psychopathology and medical illness assessment, and medication characteristics) into an online data-capture module, which will be and translated to Dutch, French, Spanish, Italian, German and Bengali Syletti.
WPs 7-9 focus on clinical trials of antipsychotics, fluoxetine and montelukast:
WP7 consists in a 12 month longitudinal naturalistic prospective pharmacovigilance study in children and adolescents treated with risperidone for different indications
WP8 consists in a 12 month longitudinal naturalistic prospective pharmacovigilance study in children and adolescents treated with fluoxetine
WP9 consists in a 12 month longitudinal naturalistic prospective pharmacovigilance study in children and adolescents treated with montelukast for bronchial asthma.
WP10-12 deal with special topics that are relevant to the overall project and the clinical studies/WPs:
WP10 contains an outline of our approach to training of all professionals and researchers that will be involved in the clinical studies.
WP11 describes our approach to the ethical issues that are relevant to the whole process of preparing and performing the clinical studies and analysing, reporting and implementing and dissemination of the results.
WP12 will address the important issue of the dissemination of the results of our project.

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