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Clinical Trials/NCT02427789
NCT02427789
Completed
Not Applicable

Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

University of Sao Paulo General Hospital1 site in 1 country40 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of Sao Paulo General Hospital
Enrollment
40
Locations
1
Primary Endpoint
Physical exercise evaluation
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
July 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Physical exercise evaluation

Time Frame: One year

Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.

Secondary Outcomes

  • Biomarkers level comparison(One year)

Study Sites (1)

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