The Taste-Mood Diagnostic Study

June 10, 2024 updated by: Ranvier Health Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS37 4AX
    • Avon
      • Bristol, Avon, United Kingdom, BS9 3AG
        • Recruiting
        • Jhoots Pharmacy
        • Contact:
          • Mohammad Din Pharmacist, BPharm
          • Phone Number: 0117 9623415
          • Email: info@jhoots.co.uk
    • Devon
      • Honiton, Devon, United Kingdom, EX14 2LY
        • Recruiting
        • Honiton Surgery
        • Contact:
    • Yorkshire
      • Hull, Yorkshire, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a diagnosis of previously untreated Major Depressive Disorder (MDD) of at least 3 weeks duration or new or recurrent MDD untreated before this episode (patients who have previously received treatment for MDD must have stopped taking antidepressant medication at least six weeks prior to entering the trial);
  • Patients requiring pharmaceutical intervention as a treatment for MDD;
  • Not suffering from any significant other mental or physical illness, such as confirmed psychosis, or end of life care.
  • Receiving stable medical therapy for 30 days or longer before screening assessments;
  • Be willing and able to comply with all visits and study related procedures;
  • Not infected with coronavirus or needing to self-isolate
  • Understands the study requirements and the treatment procedures and is able to provide written informed consent.

Exclusion Criteria:

  • Already on antidepressant medication;
  • Known or suspected hypersensitivity or intolerance to any probes, or any of their excipients;
  • Relevant history or presence upon clinical examination, of cardiac, ophthalmologic, gastro-intestinal, hepatic, or renal disease or other condition known to increase risk of side effects of the probe drugs. This exclusion criterion is determined by the Site Investigator;
  • Have a history or presence of neurological or confounding psychiatric conditions (such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, or schizophrenia),
  • Patients with a diagnosis of chronic pain.
  • Participation in another trial concurrently or within 30 days preceding enrolment that is deemed to interfere with this trial;
  • Patients who are pregnant, or who are likely to become pregnant, will be excluded from the trial, as will breastfeeding mothers;
  • Patients using supplements containing psychoactive herbs (for example St Johns Wort or 5-HTP (5-Hydroxytryptophan, also known as oxitriptan);
  • Patients regularly using psychoactive stimulants and recreational drugs (for example MDMA (ecstasy/ methyl enedioxy methamphetamine), amphetamine, LSD (lysergic acid diethylamide), cocaine);
  • Patients infected with coronavirus, or who are advised to self-isolate
  • Patients who are unable or unwilling to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Taste test
Participants newly diagnosed with depression will be presented with a series of sugar solutions of 9 different concentrations in pseudo-random order. The threshold at which each participant reliably detects the sugar taste is determined before and after a first antidepressant. Mood Questionnaires will be used to determine whether a participant is clinically depressed at the time of the taste test and 6 to 8 weeks later.
Diagnostic test: Taste test
A pseudo-randomised series of taste solutions are presented to the participant for identification as sugar or water, in order to establish their taste threshold.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in taste threshold with antidepressant treatment
Time Frame: 6 weeks (per participant)
Change in taste threshold between baseline and after ingestion of probe antidepressant
6 weeks (per participant)
Change in mood (assessed by score on the Beck Depression Inventory) with antidepressant treatment
Time Frame: 6 weeks (per participant)
Change in mood (assessed by score on the Beck Depression Inventory (BDI)) with antidepressant treatment is assessed. BDI scores may range from 0-63, where 0 demonstrates the lowest depression score and 63 the most severe depression.
6 weeks (per participant)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9)
Time Frame: 6 weeks (per participant)
Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9). PHQ9 scores range from 0-27, where 0 is the score for the least depressed patients and 27 the most severely depressed patients.
6 weeks (per participant)
Change in mood with antidepressant treatment, measured by the Generalised Anxiety Disorder 7 (GAD 7) Questionnaire
Time Frame: 6 weeks (per participant)
Change in mood with antidepressant treatment, measured by the GAD 7 Questionnaire GAD 7 scores range from 0-21, where 0 is the score for the least anxious patients and 21 the most severely anxious patients.
6 weeks (per participant)
User assessment of ease of use of the device and testing process.
Time Frame: 6 weeks (per participant)
User views on ease of the testing process will be collected. Users will be asked to give ease of use a score from 1-5, where 1 is very easy and 5 is very difficult. Participants will also be asked whether they would use the taste test again.
6 weeks (per participant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranvier Health Ltd

Investigators

  • Principal Investigator: David Adams, BDS, MSc, Ranvier Health Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ranvier BRS 2.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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