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The Taste-Mood Diagnostic Study

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ClinicalTrials.gov Identifier: NCT03645447
Recruitment Status : Not yet recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
University of the West of England
Information provided by (Responsible Party):
Ranvier Health Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Diagnostic Test: Taste test Not Applicable

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 device in the diagnosis of depression and to predict drug effectiveness.

A device has been developed to automate a taste test on the tongue from different concentrations of salt, sweet, bitter and sour solutions, which then uses a probe drug (prescribed antidepressant) to assess change in taste. This also incorporates questionnaires of mood scales.

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 having 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Intervention Model: Single Group Assignment
Intervention 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 described as diagnostic.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Taste test 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.




Primary Outcome Measures :
  1. Change in taste threshold with antidepressant treatment [ Time Frame: 28 +/- 3 days (per patient) ]
    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.

  2. Change in mood (assessed by score on the Beck Depression Inventory) with antidepressant treatment [ Time Frame: 28 days +/- 3 days (per patient) ]
    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.


Secondary Outcome Measures :
  1. Change in mood with antidepressant treatment, measured by the Clinical Global Impression Scale (CGI scale) [ Time Frame: 28 +/- 3 days (per patient) ]
    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.

  2. Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9) [ Time Frame: 28 +/- 3 days (per patient) ]
    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.

  3. Change in mood with antidepressant treatment, measured by the Hospital Anxiety and Depression scale (HADS) [ Time Frame: 28 +/- 3 days (per patient) ]
    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. Change in mood with antidepressant treatment, measured by the Quick Inventory of Depressive symptomatology (QIDS) [ Time Frame: 28 +/- 3 days (per patient) ]
    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.

  5. Validation of diagnostic algorithm, comparing the sequence of taste testing determined by the device software with the algorithm described in the software specification. [ Time Frame: 12 months (duration of trial) ]
    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.

  6. User assessment of ease of use of the device and testing process. [ Time Frame: 28 +/- 3 days (per patient) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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 who are unable or unwilling to comply with study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645447


Contacts
Contact: Helen Leach, BDS, MSc 0117 9089385 helenleach@ranvierhealth.com
Contact: David Adams, MBBS 0117 9089385 davidadams@ranvierhealth.com

Sponsors and Collaborators
Ranvier Health Ltd
University of the West of England
Investigators
Principal Investigator: Niall Kealy The Diagnostic Centre

Publications:
Responsible Party: Ranvier Health Ltd
ClinicalTrials.gov Identifier: NCT03645447     History of Changes
Other Study ID Numbers: Ranvier2.1
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ranvier Health Ltd:
Depression
Diagnostic aid
Taste

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders