To facilitate the organisation and management, the project is structured in “Work packages” which together comprise the project. STOP consists of 12 work packages (WPs). Each WP is carried out by a varying number of involved parties. The WP leader supervises and adjusts the process flow and works closely with the project office. The activity of the WP will be overseen by the chair of the working group.
WP01: Project Management (Leader: concentris / A Schwalber)
Effective project management is a central element of successful research. This is because large research projects entail a lot of administrative work. The management WP makes sure that the project achieves its objectives and delivers in time, budget and quality its milestones and deliverables. It is furthermore concerned with communication, reporting, meeting organisation, financial management and intellectual property rights. The responsibility for project management lies primarily with the coordinator who is supported by concentris.
WP02: Signal generation and meta-analysis on medication-induced suicidality (Leader: CPPR / I Wong, M Murray)
This WP will develop a novel methodology using data from spontaneous reporting systems to identify all signals of drug-induced suicidal behaviour/suicidality; a selection of which will then be investigated by meta-analytical methods to report their frequencies in published literature, where data are available. The signals generated by the two methods will then be compared in order to make recommendations with regard to the future detection and reporting of medication-associated suicidality.
WP03: Establishing Biological Sampling Methodology for Investigation of Mediators of Suicidality (Leader: KCL / S Curran, K Aitchison)
To establish methodology for biological sample collection in the child & adolescent prospective cohorts to be studied (WPs 7, 8, and 9). This WP is necessary as there are no prior clinical cohorts in children and adolescents in which all the possible relevant biological data have been collected, in order to adequately investigate mediators of suicidality, including not only the medication of interest (and its metabolites), but also confounders such as indication for which the medication is prescribed and other confounders such as the ingestion of other substances. Moreover, the type of samples that are feasible and acceptable to patients, carers, and clinical teams to collect from such cohorts, and fit for their intended purpose, may be different in children and adolescents compared to adults.
WP04: Methodology – Psychosocial Mediators of Suicidality (Leader: CIBERSAM / C Arango, C Llorente)
Psychosocial and clinical factors previously related to an increased risk for suicide and/or suicide attempts have been depression, personality disorder, substance abuse disorder, impulsivity, peer relationship problems, school problems, family history of suicidal behaviour, poor parent-child communication, stressful life events, history of sexual or physical abuse, etc. There are differences between suicidal behaviours in adults and those occurring in children and adolescents. The aims of this work package are to first consolidate the existing evidence pertaining to the psychological and sociological risk factors for suicidal behaviours in children and adolescents and then to establish and test a reliable methodology for collecting comprehensive data on these risks for use in prospective clinical drug trials in child and adolescent populations.
WP05: Development of Suicidality Assessment Tool (Leader: FCRB / J Castro-Fornieles)
The goal of this WP is to develop a low burden, reliable and efficient screening tool for suicidal ideation and suicide risk in children and adolescents specifically addressed to capture the possible influence of medication side effects or mechanism of action. The rating scale will have one form for children, one for adolescents, one form to be addressed to their parents and another form to be completed by the clinician.
WP06: E-Monitoring and Datacapture (Leader: KCL / P Santosh)
WP6 is central to converting all the assessment and monitoring instruments being used in STOP onto an online multi-media system which allows accurate measures of change across a wide range of symptoms, side-effects, psychological functions and quality of life. This will be developed with a view to being able to be used by children, adolescents, parents, teachers as well as clinicians and will be GCP compliant.
WP07: Suicidality in Prospective Cohort Study using the PERS Study subjects entering open-label pharmacovigilance (Leader: RUNMC / J Buitelaar, J Glennon)
Empirical data are lacking on the risk of antipsychotics to induce or elicite for suicidalitiy. When studying suicidality related to antipsychotic treatment, it is important to differentiate this from suicidality which is a complication of the psychiatric disorder for which the medication is prescribed, as for example both schizophrenia, bipolar disorder, and conduct disorder / severe aggression are indications for prescribing antipsychotics but have also been associated with increased risks for suicidality. Therefore the overall objective of this WP7 is to explore the frequency, nature, and course of subjectively reported and observed symptoms of suicidal ideation and suicidal behaviour possibly associated with the use of risperidone in patients newly prescribed risperidone in relation to medication variables and patients characteristics.
WP08: Suicidal Behaviour in a Prospective Observational/Naturalistic Cohort Study of Children and Adolescents Treated with Fluoxetine in Europe (EU): Piloting New Methods/Tools (Leader: CIMH / R Dittmann)
Objectives of WP 8 are 1) to compare the effect of the antidepressant compound Fluoxetine on the risk of ‘suicidal behaviour’ to non-medication approaches in newly treated in- and outpatient children and adolescents investigated in a prospective, naturalistic/observational 12-week study, followed by an extension period up to 52 weeks. 2) to compare rates of ‘suicidal behaviour’ ascertained by applying ‘current/standard’ in comparison to ‘newly developed’ (in WPs 5, 6) assessment tools in both cohorts in the prospective observational study outlined in objective 1.
WP09: A prospective controlled feasibility study of the monitoring of mental health in Children and Adolescents taking Montelukast for Asthma vs. A Control Group Unexposed to Montelukast (Leader: UCL / A Sutcliffe)
The principal objective of this WP is to use a mental health monitoring package in the general paediatric acute care setting to show feasibility in assessing the risk of adverse mental health outcomes associated with montelukast treatment for asthma in children and adolescents, including suicide, and other psychiatric morbidity in relation to this drug. Secondary objectives include the study of an established data set of 5% of the UK population which records exposure to montelukast and the development of a consensus evidence-based clinical guideline to aid the prevention, early identification and management of adverse psychiatric morbidity associated with montelukast treatment for asthma.
WP10: Training (Leader: UULM / U Schulze)
This WP aims to monitor the adherence to GCP guidelines concerning training procedures, quality standards and an appropriate conduct of the trials in terms of assessment instruments and procedures including their precise application, evaluation and documentation of results.
WP11: Ethics (Leader: UNICA / A Zuddas)
The objective of this WP is to ensure that medical-ethical considerations are integrated in all the proposed studies of the project. The studies will be conducted according to the principles of ICH-GCP and legal regulations of the European Union and national legislation. Study protocols will be approved by the relevant ethical committees prior to commencement of any trial.
WP12: Dissemination (Leader: APHP / D Purper-Ouakil)
Aims of this WP are to review and disseminate innovative methods to assess suicidaliy, progress and results of the clinical studies and to contribute to the development of guidelines for monitoring treatment emergent suicidality.