Using a Diagnostic Taste Test as a Surrogate Biomarker to Predict Drug Effectiveness in Patients With Depression (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- Change in mood (assessed by score on the Beck Depression Inventory) with antidepressant treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Taste test
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.
干预措施: Taste test (Diagnostic Test)
结局指标
主要结局
Change in mood (assessed by score on the Beck Depression Inventory) with antidepressant treatment
时间窗: 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.
Change in taste threshold with antidepressant treatment
时间窗: 6 weeks (per participant)
Change in taste threshold between baseline and after ingestion of probe antidepressant
次要结局
- Change in mood with antidepressant treatment, measured by the Generalised Anxiety Disorder 7 (GAD 7) Questionnaire(6 weeks (per participant))
- User assessment of ease of use of the device and testing process.(6 weeks (per participant))
- Change in mood with antidepressant treatment, measured by the Patient Health Questionnaire 9 (PHQ9)(6 weeks (per participant))