NCT05745194: INDEPT

Influence of Nutrition in Depression Treatment (INDEPT)

Recruiting now NA Last updated 6 August 2024

What this trial tests

NA trial testing Promotion of adherence to the MedDiet in Major Depressive Disorder - MDD in 190 participants. Currently enrolling.

Timeline

5 June 2023

Primary endpoint
31 January 2025

31 December 2025

Quick facts

Lead sponsor	Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	190
Start date	5 June 2023
Primary completion	31 January 2025
Estimated completion	31 December 2025
Sites	2 locations across Portugal

Drugs / interventions tested

• Promotion of adherence to the MedDiet

Conditions studied

• Major Depressive Disorder - MDD — all drugs for Major Depressive Disorder - MDD →

Sponsor

Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA

Who can join

Adults 18 to 70, any sex, with Major Depressive Disorder - MDD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nutritional counselling in adults promoting adherence to the Mediterranean diet as adjuvant in the treatment of major depressive disorder (INDEPT): a randomized open controlled trial study protocol.
   Sousa-Santos N, Fialho M, Madeira T, Clara C, et al · · 2023 · cited 2× · PMID 37016319 · DOI 10.1186/s12888-023-04705-z