The Effect of an Edible Algal Extract (Ulva Lactuca) on the Component of Depression in Healthy Vo… (NCT03545399) | Clinical Trial Compass
CompletedNot Applicable
The Effect of an Edible Algal Extract (Ulva Lactuca) on the Component of Depression in Healthy Volunteers With Anhedonia
90 participantsStarted 2015-06-29
Plain-language summary
The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged between 18 and 65 years
* Presenting a anhedonia with a score ≥5 on the SHAPS Scale
* Declaring feeling low for at least 4 weeks characterised by a component of depression evaluated on the QIDS-SR
* Being able to apprehend and fill in the evaluation scales
Exclusion Criteria:
* Subject with a major depressive episode as per the DSM V scale, with a HAM D \> 8, already on anxiolytic, antidepressor, neuroleptic or any other medicinal treatment liable to influence mood (e.g. benzodiazepines) in the last 30 days or using illegal psychotropic substances, or a with daily alcohol intake of more than three glasses of wine
* Presenting a psychiatric disorder or in state of post-traumatic stress or having had an electroconvulsive therapy in the last 6 months
* Female subject pregnant or breast-feeding or of childbearing age and not using effective means of contraception
* subject suffering from an allergy or intolerance to seafood products (fish, shellfish and seaweed)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.