RADAR-MDD v0.1
Research type
Research Study
Full title
Remote Assessment of Disease And Relapse in Major Depressive Disorder
IRAS ID
218215
Contact name
Matthew Hotopf
Contact email
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
An estimated 7% of the adult European population suffers from major depressive disorder (MDD) every year, representing 3.8% of all European disability-adjusted life years (DALYs) and making it the third leading cause of DALYs in Europe. Mental disorders are the largest contributor to chronic conditions affecting the European population; depressive disorder is the leading chronic condition in Europe, contributing to 11% of all Years Lived with Disability (YLD). The estimated cost of MDD in Europe in 2004 was €253 per inhabitant, corresponding with an overall cost of €118 billion; the total cost of depression represents 1% of the total economy of Europe. \n\nConventional outcome measurement in depression almost exclusively relies upon self-report, using questionnaires, rating scales or interviews. With all such assessments, symptoms are assessed retrospectively. However, symptom recall in patients with depression is biased by their dysfunctional perceptions and retrospective recall does not capture information regarding symptom variability and context reactivity. \n\nRemote measurement technology (RMT) provides a solution to these measurement problems by giving richer, objective characterisation of behaviour, cognition, speech and physiology, with excellent temporal resolution, including an ability to assess diurnal changes. \n\nRADAR-MDD is a clinical study aiming to assess the utility of multiparametric RMT in clinical populations with MDD. \nSpecifically, the aims of this study are to:\n1.\tDetermine the usability, feasibility and acceptability of, and adherence to, RMT to provide real-time objective multidimensional indications of clinical state in individuals with MDD.\n2.\tImprove and refine clinical outcome measurement using RMT as a means of identification of current clinical state\n3.\tDetermine whether multi-parametric RMT collected in populations with recurrent MDD can provide information predictive of depressive relapse and other critical outcomes. \n\nThis project is being undertaken as part of RADAR-CNS, an international consortium, receiving funding from the Innovative Medicine Initiatives 2 Joint Undertaking (grant agreement N. 115902), and receiving support from the European Union’s Horizon 2020 research and innovation programme, and the European Federation of Pharmaceutical Industries and Associations (EFPIA). COVID-19 amendment – 03/04/2020] The current study protocol currently gathers information on contextual variables to identify major changes in participant’s circumstances which may materially affect their outcomes (for example the death of a loved one) and may also impact use of RMT (e.g. a new physical health problem). Therefore, following the COVID-19 (Coronavirus) outbreak we seek approval to administer an additional set of questions to identify potential symptoms of COVID-19, in addition to changes in participants’ circumstances and routines as a result of the outbreak. These additional contextual variables may also outcomes and also impact use of RMT during this period. The questionnaire will be administered via RADAR-CNS web-based platform/active RADARCNS smartphone app every two weeks, until the pandemic ends.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
17/LO/1154
Date of REC Opinion
1 Sep 2017
REC opinion
Further Information Favourable Opinion