Clinical trial NCT05608330: Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data
Official title: Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2022-11-08
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PETRUSHKA is aimed at developing and subsequently testing a personalised approach to the pharmacological treatment of major depressive disorder in adults, which can be used in everyday NHS clinical settings.

We have collected data from patients with major depressive disorder, obtained from diverse datasets, including randomised trials as well as real-world registries (registers that hold routinely collected NHS data from the UK). These data summarise the most reliable and most up-to-date scientific evidence about benefits and adverse effects of antidepressants for depression and have been used to inform the PETRUSHKA prediction model to produce individualised treatment recommendations. The prediction model underpins a web-based decision support tool (the PETRUSHKA tool) which incorporates the patient's and clinician's preferences in order to rank treatment options and tailor the treatment to each patient.

This trial will recruit participants from the NHS within primary care in England and investigate whether the use of the PETRUSHKA tool is better than 'usual care' treatment in terms of adherence to antidepressant treatment, clinical response and quality of life, and its cost-effectiveness over a 6-months follow up.

Detailed description: The PETRUSHKA tool, employs a bespoke algorithm to identify the best antidepressant for each individual patient. The algorithm: (a) is based on a prediction model which uses a combination of advanced analytics (statistics) and machine learning methods (artificial intelligence); (b) uses a dataset which is a combination of real-world data (QResearch: https://www.qresearch.org/) from over 1 million primary care patients with depression in England and Wales, and individual participant data from about 40,000 patients recruited in randomised controlled trials; (c) incorporates preferences from patients and clinicians (especially about adverse events); (d) generates a ranked list of personalised treatment recommendations that will inform the clinical discussion between clinicians and patients, and the final treatment decision. The clinical decision aid tool is implemented in the form of a web-based application, accessible from any computer or tablet.

Eligibility criteria: Inclusion Criteria:

* Aged 18 - 74 years inclusive;
* Willing and able to give informed consent for participation in the trial;
* Clinical diagnosis of depression (either single episode or recurrent), for which an antidepressant is clinically indicated;
* Willing to start antidepressant treatment as monotherapy;
* Able to read/understand and/or complete self-administered questionnaires online in English;
* Willing to meet any clinical requirements related to taking a specific medication

Exclusion Criteria:

* Prescribed any antidepressant in the preceding 4 weeks;
* Current or historical diagnosis of ADHD, Alcohol/Substance Use Disorder, bipolar disorder, dementia, eating disorders, mania/hypomania, OCD, PTSD, psychosis/schizophrenia, Treatment Resistant Depression (having tried 2 or more antidepressants for the same depressive episode at adequate dose and time);
* Diagnosis of arrhythmias (including Q-T prolongation, heart block), recent MI, poorly controlled epilepsy, acute porphyrias;
* Require urgent mental care or admission (including suicidal intent/plans);
* Concurrently enrolled in another investigational medicinal product (IMP) trial or an interventional trial about depression;
* Participants who are currently pregnant, planning pregnancy or lactating;
* Has a medical, social or other condition which, in the investigator's opinion , may make the participant unable to comply with all the trial requirements (e.g., terminal illness - motor neuron disease).

Primary outcomes:
measure: To determine whether using the PETRUSHKA tool to "personalise" antidepressant treatment, results in an increased proportion of patients continuing the allocated treatment, compared to usual care.
timeFrame: 8 Weeks
Secondary outcomes:
measure: Self-rated change in depressive symptoms from baseline
timeFrame: Baseline, week 2, 4, 6, 8, 12, 16, 20, 24
measure: Observer-rated change in depressive symptoms from baseline
timeFrame: Baseline, week 2, 4, 6, 8, 12, 16, 20, 24
measure: The number of participants who discontinue from treatment at 8 weeks due to any cause
timeFrame: Week 8
measure: The number of participants who discontinue from treatment at 24 weeks due to any cause
timeFrame: Week 24
measure: The number of participants who discontinue from treatment at 8 weeks due to adverse events
timeFrame: Week 8
measure: The number of participants who discontinue from treatment at 24 weeks due to adverse events
timeFrame: Week 24
measure: Self-rated change in anxiety symptoms from baseline
timeFrame: Baseline, week 2, 4, 6, 8, 12, 20, and 24,
measure: Observer-rated change in anxiety symptoms from baseline
timeFrame: Baseline, week 2, 4, 6, 8, 12, 20, and 24,
measure: The impact of depression on quality of life and capability wellbeing
timeFrame: Baseline, week 4,8,12,24
measure: A reduction in risk of suicidality from baseline
timeFrame: Baseline, week 8 and 24
measure: An improvement in the functional outcome from baseline, with 0 being not at all and with 40 being very severely impaired.
timeFrame: Baseline, week 4, 8, 12 and 24
measure: A change in the health/social care costs of depression (direct and indirect) from baseline
timeFrame: Baseline, week 4,8,12 and 24
Other outcomes:
Locations:
Study officials:
References:
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