Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2022-06-06
2025-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
Taste test
A pseudo-randomised series of taste solutions are presented to the participant for identification as sugar or water, in order to establish their taste threshold.
Interventions
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Taste test
A pseudo-randomised series of taste solutions are presented to the participant for identification as sugar or water, in order to establish their taste threshold.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Ranvier Health Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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David Adams, BDS, MSc
Role: PRINCIPAL_INVESTIGATOR
Ranvier Health Ltd
Locations
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Jhoots Pharmacy
Bristol, Avon, United Kingdom
Honiton Surgery
Honiton, Devon, United Kingdom
Humber Teaching NHS Foundation Trust
Hull, Yorkshire, United Kingdom
West Walk Surgery, Yate
Bristol, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1523/JNEUROSCI.3459-06.2006.
Related Links
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Sponsor's website
Other Identifiers
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Ranvier BRS 2.1
Identifier Type: -
Identifier Source: org_study_id
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