Interventional, Randomised, Open Label, Multi-centre, Parallel-group, Controlled Study Investigating the Effects of Using the PReDicT Test to Guide the Antidepressant Treatment of Depressed Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- P1vital Products Limited
- Enrollment
- 913
- Locations
- 151
- Primary Endpoint
- Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by the QIDS-SR-16
Study Overview
Brief Summary
Depression is a very common, serious and in some cases life-threatening condition, affecting around 350 million people globally. Approximately 11% of citizens in the European Union suffer from depression at some point in their lives. Depression is associated with significant socio-economic costs and has been predicted to become the greatest cause of disability worldwide by 2030 . In 2010 it was estimated that there were approximately 30 million patients with depression in Europe, with aggregated economic costs of approximately €92 billion . Improvements in managing the treatment of depression are urgently needed to improve patient outcomes, contain rising healthcare costs, improve workplace productivity and help to address global economic and societal challenges.
While a range of effective antidepressant medications are available to treat depression, it takes 4-6 weeks after starting antidepressant treatment before a physician can detect whether the treatment is working. However, surprisingly, more than 50% of patients fail to respond to the first antidepressant treatment they are prescribed. Therefore, it often takes several months to identify an effective antidepressant treatment for the majority of patients with depression. During this time a patient's ability to work and function socially is severely impaired. Individuals may be absent from work for many weeks or months and this places a substantial burden on the economy and on healthcare resources.
Detailed Description
The study is a randomized, two-arm, multi-centre, open label, clinical investigation of a medical device, the Predicting Response to Depression Treatment Test (PReDicT Test) . It will be conducted in depressed patients in primary care settings in five European countries (UK, France, Spain, Germany and the Netherlands).
The study is divided into an 8 to 10 week clinical phase and a 40 week follow-up phase. Each participant will be in the study for a total of up to 48-50 weeks.
During the clinical phase, participants will attend between 2 and 4 study visits, depending on their study arm and their response to treatment. Some of these visits may be conducted by telephone. Participants will also complete weekly online questionnaires from home.
During the follow-up phase participants will complete online questionnaires from home every 4 weeks over a 40 week period. Study visits will not be required during the follow-up phase.
An electronic Patient Reported Outcomes (ePRO) system, accessed via a study website, will be used to collect questionnaire data and PReDicT Test responses. The ePRO system will be used to randomise participants and will issue email reminders to participants and study researchers when study-related activities are due.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female aged between 18 and 70 inclusive.
- •Diagnosed with a depressive episode by a physician (either first episode or recurrent) and requiring treatment with a selective serotonin reuptake inhibitor (SSRI) medication (excluding fluoxetine).
- •Prescribed an SSRI by a physician for the treatment of depression within 7 days prior to Visit 1, but has not yet started taking medication.
- •Is intending to start SSRI treatment within 7 days of Visit 1.
Exclusion Criteria
- •Previous history of mania.
- •Is currently taking an antidepressant medication or has stopped antidepressant treatment within 2 weeks prior to Visit
- •Requires immediate referral to alternative mental health services (e.g. where a patient seen in primary care is referred to secondary care services).
- •Presents to a physician with significant current suicidal intent requiring enhanced care.
Outcomes
Primary Outcomes
Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by the QIDS-SR-16
Time Frame: 8 weeks
QIDS-SR-16 is a standard questionnaire "The Quick Inventory of Depressive Symptomatology" (16-Item) (Self-Report). This covers questions on falling asleep, sleep during the night, waking up , sleeping too much, feeling sad ,appetite, weight, concentration , how they view themselves, thoughts of death and suicide, general interests, energy levels, feeling slowed down , feeling restless. These will be compared at baseline and after 8 weeks of treatment.
Secondary Outcomes
- Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the EQ-5D-5L(24 weeks and 48 weeks (optional))
- Compare the change from baseline on the depression and anxiety items(8 weeks)
- Compare changes in baseline of the QIDS-SR-16 score(24 weeks and 48 weeks)
- Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the QIDS-SR-16(24 weeks and 48 weeks (optional))
- Determine the change of cognitive function(8 weeks)
- Obtain further feasibility data(48 weeks)
- Compare the change from baseline in GAD-7 score(8 Weeks)
- Compare the change from baseline in self-reported social and occupational functioning(weeks 8, 24 and 48)
- Compare the change from baseline in QIDS-SR-16 scores(8 weeks)
- Increase in proportion of depressed patients showing a response to treatment at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by a reduction of >50% in the MADRS score(8 weeks)
- Increase in proportion of depressed patients showing remission from depression at week 8 when using the PReDicT Test to direct antidepressant treatment compared to treatment as usual as measured by a QIDS-SR-16 score <=5(8 Weeks)
- Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the OxCAP-MH(24 weeks and 48 weeks (optional))
- Health economic analysis on societal costs and cost-effectiveness/cost-utility of the PReDicT Test compared with Treatment as Usual as measured by the HEQ(24 weeks and 48 weeks (optional))
- Assess the acceptability and perceived value of the PReDicT Test(48 weeks)
- Device safety as required by medical devices legislation(48 weeks)