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Prescribing the Right Agent for Depression in Adults (PRADA): a Double-blind, Randomised Controlled Trial Using a Web-based Multi-modal Clinical Decision Support System and Genetic Information to Personalise Antidepressant Treatment in Diverse Clinical Settings Across the Globe

NCT07796295

Not Yet RecruitingNA

Sponsor: University of Oxford

Conditions: Major Depressive Disorder (MDD)

Interventions: PRADA Tool, PETRUSHKA Tool

Countries: Ethiopia, Pakistan, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria:

1. Aged 18-74 years inclusive;
2. Willing and able to give informed consent for participation in the trial;
3. Clinical primary diagnosis of major depressive episode, for which an antidepressant is clinically indicated;
4. PHQ-9 score of at least 10;
5. Willing and able to start antidepressant treatment as monotherapy;
6. Able to understand and answer self-administered questionnaires in their local language.

Exclusion Criteria

1. Taken an antidepressant in the preceding 4 weeks at a therapeutic dose;
2. Current or historical diagnosis (lifetime) of ADHD, bipolar disorder, dementia, mania/hypomania, psychosis/schizophrenia
3. Current or historical diagnosis (within 10 years) of any eating disorders, PTSD, OCD or alcohol/substance use disorder
4. Treatment Resistant Depression (i.e., having tried 2 or more antidepressants for the same depressive episode at adequate dose and time);
5. Known diagnosis of arrhythmias (including Q-T prolongation, heart block), recent myocardial infarction (within 5 years), difficult-to-treat epilepsy, acute porphyrias;
6. Requires urgent mental care or admission (including suicidal intent/plans);
7. Concurrently enrolled in another investigational medicinal product (IMP) trial that, in the opinion of the investigator, is likely to interfere with the PRADA trial or an interventional trial about depression;
8. Pregnant, planning pregnancy or lactating (self-reported);
9. Unable to give blood sample for genetic analysis.

Locations (3)

Addis Ababa, Ethiopia
Karachi, Pakistan
Oxford, Oxfordshire, United Kingdom