Computer tasks to predict response to antidepressants P1V-DEP-MD01,1.0
Research type
Research Study
Full title
An exploratory investigation in depressed patients initiating treatment with Citalopram, to determine the sensitivity and specificity of the P1vital® Oxford GP-Emotional Test Battery in predicting drug response and non-response.
IRAS ID
151630
Contact name
Michael Browning
Contact email
Sponsor organisation
P1vital Products Ltd
Research summary
In England over 800,000 patients each year are either newly diagnosed with depression or present with a new episode of depression in primary care. The majority of patients do not respond to the first drug prescribed and have to try several different antidepressants before an effective treatment is found. Antidepressants have a slow clinical onset of action, taking 4 to 6 weeks before changes in mood become apparent. No test exists to guide General Practitioners (GPs) as to whether their patient is responding to the prescribed successive treatments. This often results in delays of many months before patients return to good mental health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed and optimised to be sensitive to early changes in emotional bias that are indicative of successful antidepressant treatment. The current investigation is an exploratory study using the GP-ETB. It will test the predictive ability of the GP-ETB with regard to later subjective drug response and non-response. The study will recruit depressed patients from primary care settings. There are no study drugs prescribed as part of this clinical investigation. Eligible patients will have been prescribed citalopram by their GP prior to study entry. The decision to initiate treatment with citalopram will be independent of study participation. The duration of the study is 5 months. Each patient will be required to attend 3 visits and total duration of the study for the patient will be 4-6 weeks. During the visits patients will be asked to complete a variety of questionnaires and GP-ETB tasks on the computer. Sensitivity and specificity data collected during this study will be used to develop a computer algorithm intended to predict response at 4-6 weeks, based on GP-ETB data collected 1 week after initiation of antidepressant treatment.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0250
Date of REC Opinion
16 May 2014
REC opinion
Favourable Opinion