Influence of Nutrition in Depression Treatment (INDEPT) (NCT05745194) | Clinical Trial Compass
RecruitingNot Applicable
Influence of Nutrition in Depression Treatment (INDEPT)
Portugal190 participantsStarted 2023-06-05
Plain-language summary
The hypothesis to be tested by this study is that an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with elevated inflammation biomarkers, namely C-reactive protein (CRP) and Interleukin 6 (IL-6) diagnosed with Major Depression Disorder (MDD), under treatment with antidepressant medication for a period of time less than or equal to 6 months.
The main aim of this study is to understand if promoting the adherence to the MedDiet, as an adjuvant strategy in the treatment of MDD, is effective in decreasing symptoms of depression in MDD patients, with elevated levels of inflammation biomarkers.
Other specific objectives of the study are
1. To assess the association between adherence to MedDiet and changes in inflammatory biomarkers;
2. To assess the association between changes in inflammatory biomarkers with symptoms of MDD;
3. To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD;
4. To characterize the association between adherence to MedDiet and changes in health-related quality of life
5. To evaluate the economic cost-effectiveness of dietary counselling, as an adjuvant treatment in MDD.
The study will have a duration of 12 weeks, with a randomized parallel-group open controlled trial design, with two parallel groups with an allocation ratio of 1:1 - (a) intervention arm with six nutritional consultations with a registered nutritionist, promoting adherence to MedDiet, in addition to MDD Treatment-As-Usual (TAU) and (b) control group arm benefitting only from MDD TAU. A follow up assessment will be performed at 6- and 12-months.
Having into consideration an attrition of 40 percentage at the end of the intervention, the minimum sample size estimated is 190 (95 per arm).
The main outcome of the trial, changes in symptoms of depression, will be evaluated using the Beck Depression Inventory Second Edition (BDI-II).
Who can participate
Age range
18 Years – 70 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
. Aged between 18-70 years old
. Able to understand and provide informed consent
. Able to read and write
. Have a diagnosis of MDD (according to ICD-10 F32.0; F32.1; F32.2; F32.9; F33.0; F33.1; F33.2; F33.9 criteria)
. Score on the Beck Depression Inventory-II scale (BDI-II) \> 13;
. Elevated biomarkers of inflammation (CRP \> 3mg/l or IL-6 ≥ 2pg/ml )
. Able to follow a MedDiet without impeditive physical or religious limitations, allergies or intolerances
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.
What they're measuring
1
Changes in symptoms of MDD
Timeframe: Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment
Trial details
NCT IDNCT05745194
SponsorAssociacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA