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New treatment option for Major Depressive Disorder - MDD
Official title Influence of Nutrition in Depression Treatment (INDEPT)
ClinicalTrials.gov ID: NCT05745194
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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;
You likely can't join if
- Diagnosis of autoimmune diseases, thyroid dysfunction or cancer
- Diagnosis of bipolar disorder, psychotic disorders, eating disorders
- Self-reported acute infection 2 weeks prior to the blood sample collection
- Pregnancy or lactation
- Glucocorticoid medication
- Prescribed with NMDA Receptor Antagonists
See the full eligibility 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
- Being under pharmacological treatment for depressive disorder
- Diagnosis of autoimmune diseases, thyroid dysfunction or cancer
- Diagnosis of bipolar disorder, psychotic disorders, eating disorders
- Self-reported acute infection 2 weeks prior to the blood sample collection
- Pregnancy or lactation
- Glucocorticoid medication
- Prescribed with NMDA Receptor Antagonists
- Under treatment with brain stimulation techniques for the depressive episode
- Currently participating in another intervention targeting diet, physical exercise, or MDD treatment
The study team makes the final eligibility decision.
Where it's taking place
- Loures, Lisbon District, Portugal
- Leiria, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loures, Lisbon District, Portugal; Leiria, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.