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Completed

NCT Number: NCT02427789

Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo

São Paulo, 05403010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

physical exercise

Primary outcomes

  1. 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

  1. Biomarkers level comparison

    Time frame: One year

    To compare possible levels of cytokines, before and after controled physical exercise.

  2. Biomarkers level comparison

    Time frame: One year

    To compare possible levels of markers of oxidative stress, before and after controled physical exercise.

  3. Biomarkers level comparison

    Time frame: One year

    To compare possible levels of BDNF (Brain-Derived Neurotrophic Factor), before and after controled physical exercise.

  4. Biomarkers level comparison

    Time frame: One year

    To compare possible levels of Cortisol, before and after controled physical exercise.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2015
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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