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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03645447
• Other study ID #: Ranvier BRS 2.1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 2, 2021

Study information

• Verified date: June 2020
• Source: Ranvier Health Ltd
• Contact: Helen Leach, BDS, MSc
• Phone: 0117 9089385
• Email: helenleach[@]ranvierhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Diagnostic Test:
• Taste test
A device is used to present a pseudo-randomised series of taste solutions to the participant for identification, in order to establish taste thresholds.

Locations

Country	Name	City	State
United Kingdom	Jhoots Pharmacy	Bristol	Avon

Sponsors (1)

Lead Sponsor	Collaborator
Ranvier Health Ltd

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in taste threshold with antidepressant treatment	Change in taste threshold measures (sweet, salt, bitter, sour) between baseline and post-probe(s) at day 1 and 28 days after antidepressant treatment is initiated is assessed with the assistance of a taste test device.	4-6 weeks (per patient)
Primary	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.	4-6 weeks (per patient)
Secondary	Change in mood with antidepressant treatment, measured by the Clinical Global Impression Scale (CGI scale)	Changes in scores on the Clinical Global Impression scale, as assessed by the participant's general medical practitioner is recorded. This scale ranges from 0-7, where 0 is the least severely ill and 7 the most severely ill.	4-6 weeks (per patient)
Secondary	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.	4-6 weeks (per patient)
Secondary	Change in mood with antidepressant treatment, measured by the Hospital Anxiety and Depression scale (HADS)	Change in mood with antidepressant treatment, measured by the Hospital Anxiety and Depression scale (HADS). HADS scores for depression range from 0-21, where 0-7 is normal, 8-10 borderline and 11+ indicates clinical depression	4-6 weeks (per patient)
Secondary	Change in mood with antidepressant treatment, measured by the Quick Inventory of Depressive symptomatology (QIDS)	Change in mood with antidepressant treatment, measured by the Quick Inventory of Depressive symptomatology (QIDS). Scores for QIDS range from 0-27, where 0 indicates no symptoms of depression and 27 indicates the most severe depression.	4-6 weeks (per patient)
Secondary	Validation of diagnostic algorithm, comparing the sequence of taste testing determined by software with the algorithm described in the software specification.	A computerised algorithm will be used to direct the taste test to assess taste sensitivity. The algorithm has been developed to direct the taste test, indicating which taste solutions should be presented to the participant in which order. Every solution presented is recorded, along with answers given. These will be examined after testing to validate the code's ability to follow the algorithm created and properly determine taste thresholds.	12 months (duration of trial)
Secondary	User assessment of ease of use of the device and testing process.	User views on ease of use of the device and 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.	4-6 weeks (per patient)