Choosing the right antidepressant for people with unipolar depression
| ISRCTN | ISRCTN82850103 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82850103 |
| IRAS number | 286484 |
| Secondary identifying numbers | CPMS 53582, IRAS 286484 |
- Submission date
- 04/11/2022
- Registration date
- 07/11/2022
- Last edited
- 07/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Antidepressants are one of the available treatments for depression. There are many antidepressants that are licensed in the UK and any of them can be prescribed to you by your doctor. Matching antidepressant treatment to specific patients, however, is too often a matter of trial and error, with many factors influencing whether a treatment is suited to an individual. These factors may include clinical and demographic characteristics, how a person has responded to other treatments in the past, how severe their condition is and whether they have any other conditions they are being treated for.
This study aims to personalise treatment for people with depression. It uses a web-based decision support tool to predict which antidepressant works best for each individual patient, in comparison to usual care (i.e., when clinicians choose the antidepressant to prescribe based on their experience and clinical judgement).
Who can participate?
Patients aged between 18-74 years inclusive and diagnosed with a depressive disorder, who are willing to take an antidepressant but have not been treated with an antidepressant in the past 4 weeks
What does the study involve?
Participants will be invited to attend a study visit with a clinician, where they will be asked to sign a consent form and then asked some questions about their demographics and medical history. They will also be asked to answer a number of questionnaires before being allocated to either the group receiving standard care or the group using the PETRUSHKA tool. If a participant is assigned to the PETRUSHKA tool, they will be asked to express their preferences about some side effects and rank them based on how troublesome they would find them. At the end of the process, the PETRUSHKA tool will show them and their GP the three antidepressants that are most recommended for them (in ranking order), and the participant and their GP will be guided in the selection of the antidepressant to prescribe.
What are the possible benefits and risks of participating?
Participants will receive a treatment which may produce a reduction in depressive symptoms and an improvement in quality of life. However, this cannot be guaranteed. Participants will be contributing to research which will help increase our knowledge of how depression treatment may be personalised, which may help improve future treatment of patients with depression. The researchers do not expect there to be any disadvantages or increased risk in taking part in this study. All the antidepressant medications that are prescribed are approved and routinely used as part of standard care in the NHS.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
October 2018 to September 2023
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Prof. Andrea Cipriani, andrea.cipriani@psych.ox.ac.uk
Contact information
Scientific
Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
 ORCID ID |
0000-0001-5179-8321 |
|---|---|
| Phone | +44 (0)7528 439118 |
| andrea.cipriani@psych.ox.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Drug, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Personalise antidepressant treatment for unipolar depression combining individual choices, risks and big data |
| Study acronym | PETRUSHKA |
| Study hypothesis | It is hypothesised that, in comparison with usual care, using the PETRUSHKA tool to prescribe an antidepressant in people with unipolar depression will be associated with more people still taking the prescribed antidepressant after 8 weeks and will also improve their depressive symptoms |
| Ethics approval(s) | Approved 02/09/2022, South Central-Hampshire B Research Ethics Committee (2 Redmond Place London, E20 1JQ, UK; +44 (0)20 7104 8064; approvals@hrs.nhs.uk), ref: 22/SC/0240 |
| Condition | Unipolar depression |
| Intervention | The PETRUSHKA trial will be conducted in a primary care setting in the UK with participants being recruited by general practitioners (GPs) in GP practices. Secondary care settings will also be used to recruit a proportion of participants. This is a two-arm, randomised, single-blind, superiority trial comparing the PETRUSHKA tool with standard care in patients with depression in the NHS. Patients will be identified by their clinicians and screened for eligibility. Eligible patients will be provided with the patient information sheet to review and given the opportunity to ask questions. Those who wish to participate will be asked to complete an electronic informed consent form. Once a patient has consented to the trial, the GP will use a randomisation tool to fairly decide whether the patient will be in one of two arms: the PETRUSHKA tool arm or standard care. Once a patient has been randomised to an arm of the trial, they will be informed of the allocation. Following randomisation, the GP will collect data on demographics, medical history, and current medications and administer a set of baseline questionnaires which assess symptoms of depression, anxiety and suicidality. For patients randomised to standard care, the GP will proceed in the usual way and prescribe the patient an antidepressant based solely on their clinical judgement. For patients randomised to the PETRUSHKA tool, they will be asked to use the tool to rate common side effects associated with antidepressant treatments. Based on their preferences, patients will be shown a short list of antidepressants with details of the side effect profile and predicted efficacy of the treatment. The patient will then be asked to select the antidepressant they wish to be prescribed, based on the information provided. Patients will be able to ask their GP for support whilst using the tool as this is intended to be a collaborative decision-making process. All patients, regardless of the arm they are randomised to, will be followed up for 52 weeks. The primary outcome will be assessed at 8 weeks. During the follow-up period, participants will be asked to complete a set of questionnaires which assess compliance with the prescribed medication, side effects, mood, anxiety and quality of life. |
| Intervention type | Other |
| Primary outcome measure | The number of participants who are still taking the allocated antidepressants after 8 weeks, collected by trained clinicians during the study visits and documented in the trial’s case report forms |
| Secondary outcome measures | 1. Self-rated depressive symptoms measured using the 9-item Patient Health questionnaire at baseline, weeks 2, 4, 6, 8,12, 16, 20 and 24 2. Depressive symptoms measured using the observer-rated 17-item Hamilton Depression Rating Scale at baseline, weeks 8 and 24 3. The number of participants who discontinue treatment at 8 weeks due to any cause, collected by trained clinicians during the study visits and documented in the trial’s case report forms 4. The number of participants who discontinue treatment at 24 weeks due to any cause, collected by trained clinicians during the study visits and documented in the trial’s case report forms 5. The number of participants who discontinue treatment at 8 weeks due to adverse events, collected by trained clinicians during the study visits and documented in the trial’s case report forms 6. The number of participants who discontinue treatment at 24 weeks due to adverse events, collected by trained clinicians during the study visits and documented in the trial’s case report forms 7. Self-rated anxiety symptoms measured using the 7-item Generalised Anxiety Disorder Assessment at baseline, weeks 2, 4, 6, 8, 12, 20 and 24 8. Observer-rated anxiety symptoms measured using the Hamilton Anxiety Rating Scale at baseline, week 8, and 24 9. The impact of depression on quality of life and capability wellbeing, measured using the EQ-5D-5L questionnaire at baseline, weeks 4, 8, 12 and 24 10. Risk of suicidality measured using the Columbia Suicide Severity Rating Scale at baseline and weeks 8 and 24 11. Functional outcome measured using the Work and Social Adjustment Scale at baseline, weeks 4, 8, 12 and 24 12. Health/social care costs of depression (direct and indirect) measured using the PECUNIA RUM at baseline, weeks 12 and 24 |
| Overall study start date | 01/10/2018 |
| Overall study end date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 504; UK Sample Size: 504 |
| Participant inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the trial 2. Aged 18 -74 years 3. Clinical diagnosis of depressive disorder and for whom an antidepressant is clinically indicated 4. Participants willing to take antidepressant treatment, but have not been treated with antidepressants in the previous 4 weeks 5. Willing to meet any clinical requirements related to taking a specific medication 6. Able to read/understand and/or complete self-administered questionnaires online in English |
| Participant exclusion criteria | 1. Prescribed any antidepressant in the preceding 4 weeks 2. 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 two or more antidepressants for the same depressive episode at adequate dose and time) 3. Diagnosis of arrhythmias (including Q-T prolongation, heart block), recent MI, poorly controlled epilepsy, acute porphyrias 4. Require urgent mental care or admission (including suicidal intent/plans) 5. Concurrently enrolled in another investigational medicinal product (IMP) trial or an interventional trial about depression 6. Participants who are currently pregnant, planning pregnancy or lactating 7. 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) |
| Recruitment start date | 14/11/2022 |
| Recruitment end date | 01/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Coker Close
Bicester
OX26 6AT
United Kingdom
Wantage
OX12 9BN
United Kingdom
Conduit Lane
Eynsham
Witney
OX29 4QB
United Kingdom
Gosford
Kidlington
OX5 2NS
United Kingdom
University Park
Nottingham
NG7 2QW
United Kingdom
Faringdon
SN7 7YU
United Kingdom
Sponsor information
University/education
Research Governance, Ethics & Assurance (RGEA)
Joint Research Office
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | +44 (0)1865 616497 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers will present the study at national and international meetings in 2023; planned publication in high-impact peer-reviewed journals from 2024 onwards. |
| IPD sharing plan | Anonymised data from this study will be available after the publication of the results of the trial and upon request from Prof. Andrea Cipriani (andrea.cipriani@psych.ox.ac.uk) as appropriate and after consultation/agreement with the NIHR. All contractual arrangements about the datasets will be managed by the Research Services of the University of Oxford. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/11/2022: Trial's existence confirmed by the NIHR.
