Depression Clinical Trial
Official title:
Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)
The study will be looking at whether a taste test device can be used as a diagnostic aid for depression. Taste tests will be carried out before and after first use of an antidepressant (prescribed by the patient's GP) and then again a month later a further taste test will be conducted. The results of these tests will be assessed to see if they correlate with the outcome of validated mood questionnaires carried out at the first and second visits.
Research shows a clear link between taste sensitivity and depression, based on chemistry
shared by the tongue and the brain. (Heath, T.P., Melichar, J.M., Nutt, D.J., Donaldson L.F.
(2006) Human taste thresholds are modulated by serotonin and noradrenaline). The aim of this
study is to investigate the use of a taste test in the diagnosis of depression and to predict
drug effectiveness.
A device is being developed to automate the taste test with different concentrations of salt,
sweet, bitter and sour solutions. A test is carried out before and after ingesting a probe
drug (first prescribed antidepressant) to assess change in taste. Standard validated
questionnaires are used to assess mood on the day the first antidepressant is ingested and
one month later.
The first 30 participants will have taste tests conducted out not only via the device
described above, but also via a paper flow chart which similarly determines the order in
which taste solutions are presented to the participant to determine taste acuity.
The study is a single centre, open label study using the patient's prescribed antidepressant
as a probe with the primary objective of replicating previous results obtained, without the
use of a device, and using paroxetine. The study is powered to test 240 patients with the
provision built in to the protocol for an interim analysis after 120 patients have been
tested. This will lead to the generation of a robust diagnostic algorithm.
Patients will be followed up for repeat taste testing after 28 days (±7 days) of usual
clinical care, and follow up questionnaires will be completed at that visit. Patients will be
asked to complete a feedback questionnaire about their user experience and satisfaction with
treatment alone.
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