Depression is a common mental health problem affecting almost 300 million people worldwide. Antidepressants are recommended as one of the first line treatments for people with moderate-to-severe symptoms of depression. In our recent trial, PETRUSHKA, on the acute treatment of depression, we demonstrated that the PETRUSHKA Tool, an evidence-based shared decision support system to personalise antidepressant treatment, in comparison with usual care reduced by almost 40% the number of participants stopping their antidepressant early, also improving their depression and anxiety symptoms. To identify the best treatment for each individual, the PETRUSHKA Tool used clinical and demographic predictors. Pilot data show that genetic information can aid stratification of people experiencing depression and better target their treatment. Genetic data can be collected using low-cost DNA-sequencing technology in diverse clinical settings and low-resource environments. Hence, we hypothesised that individual-level pharmacogenomic information can further personalise antidepressant treatment. In this project called PRADA ("Prescribing the Right Agent for Depression in Adults"), we will develop and test in a global trial across Ethiopia, Pakistan and the UK, an evidence-based multimodal web-tool to help participants and clinicians choose the best pharmacological treatment for depression jointly, based on participant preferences and their individual clinical, demographic, cultural, and also genetic profile (PRADA Tool). We will compare the new tool with the PETRUSHKA Tool in a blind fashion, measuring adherence to antidepressant treatment, clinical response and quality of life over a 12-month follow-up.
Aged 18-74 years inclusive;
Willing and able to give informed consent for participation in the trial;
Clinical primary diagnosis of major depressive episode, for which an antidepressant is clinically indicated;
PHQ-9 score of at least 10;
Taken an antidepressant in the preceding 4 weeks at a therapeutic dose;
Current or historical diagnosis (lifetime) of ADHD, bipolar disorder, dementia, mania/hypomania, psychosis/schizophrenia
Current or historical diagnosis (within 10 years) of any eating disorders, PTSD, OCD or alcohol/substance use disorder
Treatment Resistant Depression (i.e., having tried 2 or more antidepressants for the same depressive episode at adequate dose and time);
Parallel
PRADA Tool
Other interventionThe PRADA Tool will incorporate a personalised evidence-based prediction model based on participants' demographic and clinical characteristics, their individual preferences on adverse events and specific symptom clusters, and information about their pharmacogenetic profile. The tool will be delivered at the baseline visit. Once particpants have provided their preferences on adverse events and symptom clusters, the participant and clinician will then choose one antidepressant from a personalised list of ranked antidepressants.
PETRUSHKA Tool
Other interventionThe PETRUSHKA Tool use participants' demographic and clinical characteristics together with individual preferences on adverse events to personalise antidepressant treatment. To preserve the blinding, the PETRUSHKA Tool used in the PRADA Trial has been modified to collect pharmacogenetic data and preferences on symptom clusters, but this information will not be used at all to inform decisions in the PETRUSHKA Tool. The tool will be delivered at the baseline visit. Once particpant has provided their preferences on adverse events and symptom clusters, the participant and clinician will then choose one antidepressant from a personalised list of ranked antidepressants.
All-cause treatment discontinuation
To determine whether using the PRADA Tool to "personalise" antidepressant treatment, results in an increased proportion of participants continuing the allocated treatment, compared to the PETRUSHKA Tool.
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University of Oxford
Lead sponsor
King's College London
Collaborator
Centre for Addiction and Mental Health
Collaborator
Addis Ababa University
Collaborator
University of Bristol
Collaborator
University of Bern
Collaborator
University of Manchester
Collaborator
Pakistan Institute of Living and Learning
Collaborator
MQ Mental Health Researh
Collaborator
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