Unipolar depression Mental and Behavioural Disorders
Conditions
Interventions
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
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed