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

Summary

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

OTHER

PRADA Tool

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.

OTHER

PETRUSHKA Tool

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.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Centre for Addiction and Mental Health

  collaborator OTHER

• Addis Ababa University

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• University of Bern

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• Pakistan Institute of Living and Learning

  collaborator OTHER

• MQ Mental Health Researh

  collaborator UNKNOWN

• University of Oxford

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2027-12-31

Completion

2028-10-31

Countries

• Ethiopia
• Pakistan
• United Kingdom

Study Locations