Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder: A Randomized Open Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 4
- 主要终点
- Changes in symptoms of MDD
研究概览
简要总结
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
- To assess the association between adherence to MedDiet and changes in inflammatory biomarkers;
- To assess the association between changes in inflammatory biomarkers with symptoms of MDD;
- To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD;
- To characterize the association between adherence to MedDiet and changes in health-related quality of life
- 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).
详细描述
To test the study´s hypothesis, namely if an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with MDD and elevated inflammation biomarkers, the following objectives will be assessed.
The main objective of the trial is:
1.To assess the effectiveness of dietary counselling promoting MedDiet, as an adjuvant treatment of MDD, to decrease depressive symptoms in adults diagnosed with MDD and having elevated inflammation biomarkers (CRP, IL-6).
Specific objectives are:
- To assess the association between adherence to MedDiet and changes in inflammatory biomarkers
- To assess the association between changes in inflammatory biomarkers with symptoms of MDD
- To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD
- Characterize the association between adherence to MedDiet and changes in health-related quality of life
- To evaluate the economic cost-effectiveness of dietary counselling, as an adjuvant treatment in MDD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The researchers responsible for the data collection at the end of the trial and follow up assessments will be hired and trained by the study staff exclusively for that task to mitigate potential bias.
The statistical analysis will be performed by researchers, prior to the unblinding of participants. The unmasking of participants group allocation will only occur after the statistical analysis of the clinical trial results at 12-week is performed.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in symptoms of MDD
时间窗: Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment
Symptoms of depression will be assessed with the self-administered Beck Depression Inventory-II (BDI-II) scale. To measure changes in the main outcome, the score of the BDI-II will be used categorically, considering the cut-offs proposed: 0-13 minimal depression; 14-19 mild depression; 20-28 moderate depression; 29-63 severe depression. The success measure will be a downgrade of category in the severity of depressive symptoms. The analysis of the score of the BDI-II will also be performed using the scale score as a continuous variable.
次要结局
- Inflammation biomarkers (IL-6 and/or CRP)(Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment)
研究者
Maria João Heitor
Head of Psychiatry, Principal Investigator
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA