CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 913 enrolled
Drug / intervention
PReDicT Test +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02790970
NCT02790970N/ACompleted

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

P1vital Products Limited·interventional·Posted Jun 6, 2016·Updated Mar 5, 2020

In Brief

A clinical study evaluating PReDicT Test and Treatment as Usual for Depression. Completed, enrolled 913 participants across 76 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesFrance, Germany, Netherlands, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 6, 2016
Enrollment StartMay 1, 2016
Primary CompletionNov 30, 2018
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.1 years ago

Interventions

PReDicT Testdevice

PReDicT Test, when completed 7-9 days after starting antidepressant treatment, is able to predict a patient's subsequent response to that antidepressant treatment 4-6 weeks later

Treatment as Usualother

Patients treated by the clinician conventionally using signs and symptoms to determine treatment changes or medication changes.