NCT03645447

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable depression

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
3.8 years until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

July 18, 2018

Last Update Submit

June 10, 2024

Conditions

Depression

Keywords

DepressionDiagnostic aidTaste

Outcome Measures

Primary Outcomes (2)

  • Change in taste threshold with antidepressant treatment

    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

    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 Outcomes (3)

  • Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9)

    6 weeks (per participant)

  • Change in mood with antidepressant treatment, measured by the Generalised Anxiety Disorder 7 (GAD 7) Questionnaire

    6 weeks (per participant)

  • User assessment of ease of use of the device and testing process.

    6 weeks (per participant)

Study Arms (1)

Taste test

EXPERIMENTAL

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

Interventions

Taste testDIAGNOSTIC_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.

Taste test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Already on antidepressant medication;
  • Known or suspected hypersensitivity or intolerance to any probes, or any of their excipients;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jhoots Pharmacy

Bristol, Avon, BS9 3AG, United Kingdom

RECRUITING

Honiton Surgery

Honiton, Devon, EX14 2LY, United Kingdom

RECRUITING

Humber Teaching NHS Foundation Trust

Hull, Yorkshire, United Kingdom

RECRUITING

West Walk Surgery, Yate

Bristol, BS37 4AX, United Kingdom

RECRUITING

Related Publications (1)

  • Heath TP, Melichar JK, Nutt DJ, Donaldson LF. Human taste thresholds are modulated by serotonin and noradrenaline. J Neurosci. 2006 Dec 6;26(49):12664-71. doi: 10.1523/JNEUROSCI.3459-06.2006.

    PMID: 17151269BACKGROUND

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • David Adams, BDS, MSc

    Ranvier Health Ltd

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Leach, BDS, MSc

CONTACT

07983054029helenleach@ranvierhealth.com

David Adams, MBBS

CONTACT

07539440372davidadams@ranvierhealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Taste tests will be undertaken, in order to establish taste thresholds. Observation of changes in taste thresholds with change in mood following antidepressant treatment may help develop a diagnostic test for depression. The taste test will not assist diagnosis of depression for the group of participants in this study, so the primary purpose is not diagnostic.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 24, 2018

Study Start

June 6, 2022

Primary Completion

December 31, 2024

Study Completion

February 28, 2025

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)