Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Study Overview
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Brief Summary
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Depression is a disorder that causes major harm to physical health and social life. It induces isolation, reduced physical and work capacity and increasing the risk of death. In contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive functions, stimulation of brain plasticity and resilience, in addition to promoting self-esteem and social interaction. The precise mechanisms by which exercise improves symptoms of depression are not fully clear, but it is probably multifactorial. In this project, the investigators aim to investigate variables that provide additional information about biomarkers involved in the pathophysiology of depression and therapeutic response to exercise. The investigators expect to find changes in biomarkers associated with potential mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived neurotrophic factor (BDNF), cortisol) after exercise program and the role in the therapeutics of depression. To evaluate functional assessment indices will be used ergospirometry, a test that determines the respiratory, cardiovascular and metabolic activity. Overall, this project will help to investigate alternative adjunctive treatments for depression and their associated biomarkers with response.

Official Title
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Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Other: Physical Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Depression Disorder According Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria Score higher or equal 18 in Hamilton Depression Rating Scale Age between 18 and 55 years old Exclusion Criteria: Unstable Clinical Diseases Patients Unable to make Physical Exercises Present frequencies below 90% attendance in the program aerobic fitness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In this group patients will not have physical exercises | |
| Active Comparator: Physical Exercise<br>In this group patients will make physical exercise | Other: Physical Exercise<br>* physical exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical exercise evaluation | Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers level comparison | To compare possible levels of cytokines, before and after controled physical exercise. | One year | 
| Biomarkers level comparison | To compare possible levels of markers of oxidative stress, before and after controled physical exercise. | One year | 
| Biomarkers level comparison | To compare possible levels of BDNF (Brain-Derived Neurotrophic Factor), before and after controled physical exercise. | One year | 
| Biomarkers level comparison | To compare possible levels of Cortisol, before and after controled physical exercise. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers, Physical exercise, Neuroprotection, ergospirometry, Major Depressive Disorder