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
|Condition or disease||Intervention/treatment||Phase|
|Depression||Diagnostic Test: Taste test||Not Applicable|
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)|
|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|
|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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
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
|Contact: Helen Leach, BDS, MSc||0117 email@example.com|
|Contact: David Adams, MBBS||0117 firstname.lastname@example.org|
|Principal Investigator:||Niall Kealy||The Diagnostic Centre|