Using taste tests to help diagnose depression

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

This study is testing if a taste test can help doctors diagnose depression by seeing how taste sensitivity changes before and after starting an antidepressant in people with depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ranvier Health Ltd (Industry-sponsored)
• Locations: 4 sites (Bristol, Avon and 3 other locations)
• Trial ID: NCT03645447 on ClinicalTrials.gov

What this trial studies

This study investigates whether a taste test device can serve as a diagnostic aid for depression by assessing taste sensitivity before and after the administration of a prescribed antidepressant. Participants will undergo taste tests and complete validated mood questionnaires at the start of treatment and again six to eight weeks later. The study aims to correlate changes in taste sensitivity with mood improvements, building on previous pilot study results. It will involve 240 patients and includes an interim analysis after 120 participants.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with untreated Major Depressive Disorder who require pharmaceutical intervention.

Not a fit: Patients currently on antidepressant medication or those with significant other mental or physical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel method for diagnosing depression and predicting the effectiveness of antidepressant medications.

How similar studies have performed: While this approach is based on previous findings linking taste sensitivity and depression, it represents a novel application that has not been extensively tested in this context.

Eligibility criteria

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.

Where this trial is running

Bristol, Avon and 3 other locations

• Jhoots Pharmacy — Bristol, Avon, United Kingdom (Recruiting)
• Honiton Surgery — Honiton, Devon, United Kingdom (Recruiting)
• Humber Teaching NHS Foundation Trust — Hull, Yorkshire, United Kingdom (Recruiting)
• West Walk Surgery, Yate — Bristol, United Kingdom (Recruiting)

Study contacts

• Principal investigator: David Adams, BDS, MSc — Ranvier Health Ltd
• Study coordinator: Helen Leach, BDS, MSc

Conditions Depression; Diagnostic aid; Taste