What is this study trying to find out about Major Depressive Disorder?

This study is examining whether counseling to follow the Mediterranean Diet can reduce depression symptoms in adults with Major Depressive Disorder who have high levels of inflammation. Researchers want to see if adding dietary advice to usual medication helps improve mood and health. The study is sponsored by the Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA.

Who may be eligible for this Major Depressive Disorder clinical trial?

Adults aged 18 to 70 years diagnosed with Major Depressive Disorder and elevated inflammation markers may be eligible. Participants should be under antidepressant treatment for up to 6 months and able to follow the Mediterranean Diet. People with certain medical conditions or other treatments may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Major Depressive Disorder clinical trial?

Study-related care, including dietary counseling and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 70Years

All Genders

ID05745194

Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder A Randomized Open Controlled Trial Study

Led by Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA · Updated on 2024-08-06

190

Participants Needed

Research Sites

47 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether promoting adherence to the Mediterranean Diet MedDiet can reduce symptoms of depression in adults diagnosed with Major Depressive Disorder MDD who have elevated inflammation markers such as C-reactive protein CRP and Interleukin 6 IL-6. The study aims to assess if adding dietary counseling to usual antidepressant medication treatment can improve depressive symptoms, inflammatory markers, quality of life, and the economic cost-effectiveness of care. This is a randomized, open controlled trial lasting 12 weeks with follow-up assessments at 6 and 12 months. Participants will be assigned to one of two groups the intervention group receives six personalized nutrition consultations over 10 weeks to encourage adherence to the MedDiet alongside their usual depression treatment, while the control group continues with their usual depression treatment alone. The dietary advice emphasizes increasing intake of olive oil, vegetables, fruits, legumes, fish, nuts, and poultry, and reducing intake of cream, butter, processed meats, sugary drinks, pastries, and fried foods. There are no calorie or weight change goals. During the study, participants will be evaluated at baseline, 12 weeks, 6 months, and 12 months for changes in depression symptoms using the Beck Depression Inventory-II BDI-II and inflammatory biomarkers. Researchers will also monitor quality of life and analyze cost-effectiveness. The trial plans to recruit about 700 participants, expecting 190 with elevated inflammation to complete the study. Safety and adherence will be tracked throughout the study period.

CONDITIONS

Brief Title

Influence of Nutrition in Depression Treatment (INDEPT)

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Aged between 18-70 years old
Able to understand and provide informed consent
Able to read and write
Diagnosed with Major Depressive Disorder according to ICD-10 criteria
Beck Depression Inventory-II score greater than 13
Elevated inflammation biomarkers (CRP > 3mg/l or IL-6 ≥ 2pg/ml)
Able to follow the Mediterranean Diet without physical or religious limitations, allergies, or intolerances
Currently under pharmacological treatment for depressive disorder

You will not qualify if you...

Diagnosis of autoimmune diseases, thyroid dysfunction, or cancer
Diagnosis of bipolar disorder, psychotic disorders, or eating disorders
Acute infection within 2 weeks before blood sample collection
Pregnancy or lactation
Use of glucocorticoid medication
Prescribed NMDA Receptor Antagonists
Undergoing brain stimulation treatments for depression
Currently participating in another intervention targeting diet, exercise, or depressive disorder treatment

Research Team

Nuno Sousa-Santos, BSc

Cátia Clara, BSc

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here