The Taste-Mood Diagnostic Study

Depression Clinical Trial

Official title: Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)

Status Recruiting

Clinical Trial Summary

The study looks 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 six to eight weeks 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.

Clinical Trial Description

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 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 then again six to eight weeks later.

The study is a single centre, open label study using the patient's prescribed antidepressant as a probe with the primary objective of building on previous results obtained in a pilot study which used paroxetine as the probe drug (whether or not this was the drug chosen for treatment). The study is powered to test 240 patients, with a provision built in to the protocol for an interim analysis after 120 patients.

Participants will be followed up after six to eight weeks of usual clinical care, by means of follow up questionnaires. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT03645447
• Study type: Interventional
• Source: Ranvier Health Ltd
• Contact: Helen Leach, BDS, MSc
• Phone: 07983054029
• Email: helenleach@ranvierhealth.com
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Completion date: February 28, 2025