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

Sponsor
University of Oxford
Study ID
NCT07796295
Status
Not Yet Recruiting

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Conditions

  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • PRADA Tool — OTHER
    The 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
    The 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.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
2,142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PRADA Tool
    A web-based clinical decision-support system for participants and clinicians to enable personalised antidepressant treatment decision-making, using clinical and demographic predictors, pharmacogenomic information and individual preferences about adverse events. At week 8, participants who consent to the optional Polygenic Score (PGS) sub-study will be randomised to receive either the Polygenic Score (PGS) material alone, or Polygenic Score (PGS) material with psychiatric genetic counselling (1:1, factorial)
  • Active Comparator: PETRUSHKA Tool
    A web-based clinical decision-support system to enable personalised antidepressant treatment decision-making, using clinical and demographic predictors, and individual preferences about adverse events, but not pharmacogenomic information. At week 8, participants who consent to the optional Polygenic Score (PGS) sub-study will be randomised to receive either the Polygenic Score (PGS) material alone, or Polygenic Score (PGS) material with psychiatric genetic counselling (1:1, factorial)

Primary Outcome Measure

All-cause treatment discontinuation [ Time Frame: Baseline to week 8 ]

Central Contacts

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