Abstract
BackgroundAntidepressant medication is commonly used to treat depression. However, many patients do not respond to the first medication prescribed and improvements in symptoms are generally only detectable by clinicians 4–6 weeks after the medication has been initiated. As a result, there is often a long delay between the decision to initiate an antidepressant medication and the identification of an effective treatment regimen.Previous work has demonstrated that antidepressant medications alter subtle measures of affective cognition in depressed patients, such as the appraisal of facial expression. Furthermore, these cognitive effects of antidepressants are apparent early in the course of treatment and can also predict later clinical response. This trial will assess whether an electronic test of affective cognition and symptoms (the Predicting Response to Depression Treatment Test; PReDicT Test) can be used to guide antidepressant treatment in depressed patients and, therefore, hasten treatment response compared to a control group of patients treated as usual.Methods/designThe study is a randomised, two-arm, multi-centre, open-label, clinical investigation of a medical device, the PReDicT Test. It will be conducted in five European countries (UK, France, Spain, Germany and the Netherlands) in depressed patients who are commencing antidepressant medication. Patients will be randomised to treatment guided by the PReDicT Test (PReDicT arm) or to Treatment as Usual (TaU arm). Patients in the TaU arm will be treated as per current standard guidelines in their particular country. Patients in the PReDicT arm will complete the PReDicT Test after 1 (and if necessary, 2) weeks of treatment. If the test indicates non-response to the treatment, physicians will be advised to immediately alter the patient’s antidepressant therapy by dose escalation or switching to another compound. The primary outcome of the study is the proportion of patients showing a clinical response (defined as 50% or greater decrease in baseline scores of depression measured using the Quick Inventory of Depressive Symptoms – Self-Rated questionnaire) at week 8. Health economic and acceptability data will also be collected and analysed.DiscussionThis trial will test the clinical efficacy, cost-effectiveness and acceptability of using the novel PReDicT Test to guide antidepressant treatment selection in depressed patients.Trial registrationClinicalTrials.gov, ID: NCT02790970. Registered on 30 March 2016.
Highlights
Antidepressant medication is commonly used to treat depression
To determine whether use of the PReDicT Predicting Response to Depression Treatment Test (Test) to direct antidepressant treatment results in an increased proportion of depressed patients showing a response to treatment at week 8 compared to Treatment as Usual (TaU), where response is defined as a decrease of 50% or more from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) scores [10]
This trial provides a rigorous assessment of the clinical effectiveness as well as economic value and overall acceptability of deploying the PReDicT Test to guide antidepressant treatment of depressed patients
Summary
This trial provides a rigorous assessment of the clinical effectiveness as well as economic value and overall acceptability of deploying the PReDicT Test to guide antidepressant treatment of depressed patients. The PReDicT Test used in this trial has been developed as part of a translational research programme which investigates treatment mechanism in depression, largely utilising non-clinical human models of cognition in controlled laboratory settings, [12] This trial, provides an important opportunity to test the potential benefits of using recent advances in cognitive neuroscience to improve patient care in mental health. Endnotes 1Note an upper limit of 70 years was included as consultation with primary-care clinicians during study design suggested that older patients are often started on a reduced dose of antidepressants which is gradually titrated over the course of 1–2 weeks This pattern of treatment would result in the PReDicT test being completed while a patient was on a potentially subtherapeutic dose
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