DepressionNCT03645447
The Taste-Mood Diagnostic Study
A study testing Taste test in people with Depression, run by Ranvier Health Ltd at 4 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Taste test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 6 Jun 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Jhoots Pharmacy
Bristol, Avon, BS9 3AG
West Walk Surgery, Yate
Bristol, BS37 4AX
Honiton Surgery
Honiton, Devon, EX14 2LY
Humber Teaching NHS Foundation Trust
Hull, Yorkshire
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Taste test
- Keywords
- Depression, Diagnostic aid, Taste
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Taste test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in taste threshold with antidepressant treatment
Change in taste threshold between baseline and after ingestion of probe antidepressant
Measured: 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.
Measured: 6 weeks (per participant)
Secondary outcomes (3)
Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9)
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.
Measured: 6 weeks (per participant)
Change in mood with antidepressant treatment, measured by the Generalised Anxiety Disorder 7 (GAD 7) Questionnaire
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.
Measured: 6 weeks (per participant)
User assessment of ease of use of the device and testing process.
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.
Measured: 6 weeks (per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start6 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Why it stopped: New study sites being added
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ranvier Health Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Leach, BDS, MSc, Principal investigator, Ranvier Health Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645447
- Sponsor's protocol ID
- Ranvier BRS 2.1
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2018
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17151269
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)
- ClinicalTrials.gov ID
- NCT03645447
- Acronym / sponsor ID
- Ranvier BRS 2.1
- Conditions
- Depression
- Keywords
- Depression, Diagnostic aid, Taste
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: New study sites being added
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ranvier Health LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Taste test | Experimental | Diagnostic Test: Taste testParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taste testA pseudo-randomised series of taste solutions are presented to the participant for identification as sugar or water, in order to establish their taste threshold. | Diagnostic test | Taste test |
Primary outcome
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
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.
3 secondary outcomes
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 Generalised Anxiety Disorder 7 (GAD 7) Questionnaire
Time frame: 6 weeks (per participant)
User assessment of ease of use of the device and testing process.
Time frame: 6 weeks (per participant)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Background: PubMed 17151269Heath 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Leach, BDS, MSc principal investigator
Ranvier Health Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taste test in people with Depression, run by Ranvier Health Ltd at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in taste threshold with antidepressant treatment (time frame: 6 weeks (per participant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.