Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Physical Exercise: Daily walking. Participants will be given an activity band to self-monitor the number of steps they walk each day during the 12-week intervention period. Each participant must reach a certain number of daily steps with a progressive goal adjusted to the number of steps from the previous week. The goal is set considering the superior number to the median of steps of the preceding week. Weekly combined exercise sessions (aerobic + strength exercise) 2 sessions of 60 minutes per week in a 12-week program. The exercise intervention will combine the use of elastic bands and the body weight. First, 5 minutes of warm-up; second, training circuit with low-intensity strength exercises alternating work and rest times using rhythmic music. Upper, lower and middle body exercises will alternate. The program will progress in intensity, work: rest ratio, and technical difficulty of the exercises. At the end of the main part, there will be a cool-down and stretching for 5 minutes.

Antidepressant medication (ADM): Patients will receive their standard antidepressant treatment prescribed by their psychiatrist.

Study summary

The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are:

* What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise?
* How effective is a physical exercise program in MDD patients in real-life conditions?

The experimental group will receive an exercise intervention as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). Researchers will compare to a control group, which will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity. The aim is to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.

Eligibility

Primary outcome measure(s)

• Inflammatory and oxidative stress biomarkers — 1. Before randomization; 2. 12-weeks after the beggining of intervention; 3. 1 year after randomization
  Nrf2 activity will be measured in circulating monocytes and through transcriptomic analysis of redox and inflammation related genes. Plasma levels of hs C-reactive protein (CRP), interleukin 6 (hs-IL-6) and tumoral nechrosis factor alfa (hs- TNF-alfa) will be analyzed.
• Brain imaging — 1. Before randomization; 2. 12 Weeks after the beggining of intervention
  It will be evaluated using Magnetic Resonance Imaging. Four different sequences will be acquired: a) a T2-FLAIR sequence; b) a 3D T1w MPRAGE sequence; c) a Diffusion Weighted sequence and d) a T2 resting-state sequence. These data will be used to discard any neurological issues, to evaluate structural changes, and for other images coregistration, to evaluate the integrity of white matter and structural connectivity, and to evaluate functional connectivity.
• Clinical evaluation — 1. Before Randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization
  The change in depression symptoms will be measured with the HAM-D17 scale. Duration of illness, number of episodes, current treatments, resistance antidepressant treatment index (Thase) will also be assessed.

Trial sites (5)

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