PReDicT: Predicting Response to Depression Treatment
Research type
Research Study
Full title
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.
IRAS ID
201455
Contact name
Jonathan Kingslake
Contact email
Sponsor organisation
P1vital Products Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 29 days
Research summary
P1vital® Products Limited has developed a computerised test, called the PReDicT Test which is designed to predict whether a patient will respond to antidepressant treatment. A patient who has depression will complete the PReDicT test before starting their medicine and after taking it for about a week. The test measures how medication changes the way a patient responds to emotions. If the test says the medication is having no effect, then the physician can change the medication after a week rather than waiting weeks to see if the patient feels better or not. \n\nThis study investigates whether, after 8 weeks of antidepressant medication, using the PReDicT test to guide treatment leads to more patients experiencing an improvement in their symptoms of depression than when the test is not used.\n\nApproximately 1200 primary care patients who, in the opinion of their physician, require treatment with an antidepressant medication will be recruited. 600 patients will be recruited from primary care in England, and 150 patients each from Spain, The Netherlands, Germany and France. Patients will be randomised to receive either treatment guided by the PReDicT test (PReDicT group) or Treatment as Usual (TaU group). Patients in the PReDicT group will be tested using the PReDicT test at baseline and then again after 1 and 2 weeks of treatment and will, if the PReDicT Test indicates that they are unlikely to respond, have their treatment altered by their physician. Treatment of patients in the TAU group will not be guided by the PReDicT test. The primary outcome is the proportion of patients responding to treatment at week 8-10 in the PReDicT group compared to the TaU group. The study will follow patients up using online questionnaires for 1 year.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0095
Date of REC Opinion
27 Apr 2016
REC opinion
Further Information Favourable Opinion