Back to resultsPersonalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data (PETRUSHKA)
Primary Purpose
Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PETRUSHKA tool
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Depression
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PETRUSHKA tool
Usual Care
Arm Description
The intervention is the PETRUSHKA web-based App (also called PETRUSHKA tool), a clinical decision-support system that incorporates a personalised evidence-based prediction model with individual patient preferences, to prescribe the best antidepressant to adults with depression
Routine care delivered in the NHS (i.e. selection of the antidepressant based primarily on the clinicians' judgement) termed 'usual care' in this study.
Outcomes
Primary Outcome Measures
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.
The number of participants who are still taking the allocated antidepressants after 8 weeks.
Secondary Outcome Measures
Self-rated change in depressive symptoms from baseline
Self-rated change in depressive symptoms measured using the 9-item Patient Health questionnaire
Observer-rated change in depressive symptoms from baseline
Change in depressive symptoms measured using the observer-rated 17-item Hamilton Depression Rating Scale
The number of participants who discontinue from treatment at 8 weeks due to any cause
Discontinuation from treatment due to any cause
The number of participants who discontinue from treatment at 24 weeks due to any cause
Discontinuation from treatment due to any cause
The number of participants who discontinue from treatment at 8 weeks due to adverse events
Discontinuation from treatment due to adverse events only
The number of participants who discontinue from treatment at 24 weeks due to adverse events
Discontinuation from treatment due to adverse events only
Self-rated change in anxiety symptoms from baseline
Self-rated change in anxiety symptoms measured using the 7-item Generalised Anxiety Disorder Assessment
Observer-rated change in anxiety symptoms from baseline
Observer-rated change in anxiety symptoms using the Hamilton Anxiety Rating Scale
The impact of depression on quality of life and capability wellbeing
EQ-5D-5L questionnaire (self-rated)
A reduction in risk of suicidality from baseline
Columbia Suicide Severity Rating Scale (observer-rated), ranging 1-5, where 1 is least severe and 5 is most severe.
An improvement in the functional outcome from baseline, with 0 being not at all and with 40 being very severely impaired.
Work and Social Adjustment Scale (self-rated)
A change in the health/social care costs of depression (direct and indirect) from baseline
Health Economics Questionnaire (self-rated)
Full Information
NCT ID
NCT05608330
First Posted
October 21, 2022
Last Updated
October 31, 2022
Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT05608330
Brief Title
Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data
Acronym
PETRUSHKA
Official Title
Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Assessors will be blind when administering rating scales at week 8 and 24, and statisticians will be blind to the allocated treatment during analysis.
Allocation
Randomized
Enrollment
504 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PETRUSHKA tool
Arm Type
Experimental
Arm Description
The intervention is the PETRUSHKA web-based App (also called PETRUSHKA tool), a clinical decision-support system that incorporates a personalised evidence-based prediction model with individual patient preferences, to prescribe the best antidepressant to adults with depression
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Routine care delivered in the NHS (i.e. selection of the antidepressant based primarily on the clinicians' judgement) termed 'usual care' in this study.
Intervention Type
Other
Intervention Name(s)
PETRUSHKA tool
Intervention Description
In the experimental arm, the PETRUSHKA tool will automatically select the antidepressants that have the best profile in terms of efficacy and acceptability for each individual participant (based on their baseline demographic and clinical characteristics) and then ask the participant to provide their preferences about common (and non-serious) adverse events. Based on patient's preferences and their individual characteristics, the PETRUSHKA tool will then identify the three best antidepressants for the participant. The clinician and the participant will be presented with an overall recommendation (in the format of a pictogram) showing how strongly each antidepressant is recommended for that individual patient. Via a shared decision-making process, the participant and the clinician will then agree on which antidepressant to choose from the shortlist.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Any antidepressant prescribed by clinician based upon their clinical judgement.
Primary Outcome Measure Information:
Title
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.
Description
The number of participants who are still taking the allocated antidepressants after 8 weeks.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Self-rated change in depressive symptoms from baseline
Description
Self-rated change in depressive symptoms measured using the 9-item Patient Health questionnaire
Time Frame
Baseline, week 2, 4, 6, 8, 12, 16, 20, 24
Title
Observer-rated change in depressive symptoms from baseline
Description
Change in depressive symptoms measured using the observer-rated 17-item Hamilton Depression Rating Scale
Time Frame
Baseline, week 2, 4, 6, 8, 12, 16, 20, 24
Title
The number of participants who discontinue from treatment at 8 weeks due to any cause
Description
Discontinuation from treatment due to any cause
Time Frame
Week 8
Title
The number of participants who discontinue from treatment at 24 weeks due to any cause
Description
Discontinuation from treatment due to any cause
Time Frame
Week 24
Title
The number of participants who discontinue from treatment at 8 weeks due to adverse events
Description
Discontinuation from treatment due to adverse events only
Time Frame
Week 8
Title
The number of participants who discontinue from treatment at 24 weeks due to adverse events
Description
Discontinuation from treatment due to adverse events only
Time Frame
Week 24
Title
Self-rated change in anxiety symptoms from baseline
Description
Self-rated change in anxiety symptoms measured using the 7-item Generalised Anxiety Disorder Assessment
Time Frame
Baseline, week 2, 4, 6, 8, 12, 20, and 24,
Title
Observer-rated change in anxiety symptoms from baseline
Description
Observer-rated change in anxiety symptoms using the Hamilton Anxiety Rating Scale
Time Frame
Baseline, week 2, 4, 6, 8, 12, 20, and 24,
Title
The impact of depression on quality of life and capability wellbeing
Description
EQ-5D-5L questionnaire (self-rated)
Time Frame
Baseline, week 4,8,12,24
Title
A reduction in risk of suicidality from baseline
Description
Columbia Suicide Severity Rating Scale (observer-rated), ranging 1-5, where 1 is least severe and 5 is most severe.
Time Frame
Baseline, week 8 and 24
Title
An improvement in the functional outcome from baseline, with 0 being not at all and with 40 being very severely impaired.
Description
Work and Social Adjustment Scale (self-rated)
Time Frame
Baseline, week 4, 8, 12 and 24
Title
A change in the health/social care costs of depression (direct and indirect) from baseline
Description
Health Economics Questionnaire (self-rated)
Time Frame
Baseline, week 4,8,12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30763612
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
26803397
Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Personalise Antidepressant Treatment for Unipolar Depression Combining Individual Choices, Risks and Big Data
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