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Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

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ClinicalTrials.gov Identifier: NCT02427789
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Physical Exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Study Start Date : March 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
In this group patients will not have physical exercises
Active Comparator: Physical Exercise
In this group patients will make physical exercise
Other: Physical Exercise
physical exercise




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427789


Locations
Brazil
University of São Paulo
São Paulo, Brazil, 05403010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Rodrigo Machado-Vieira, Phd University of São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02427789     History of Changes
Other Study ID Numbers: HCLim27/FAPESP2012/20002-5
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: April 29, 2015
Last Verified: January 2013

Keywords provided by University of Sao Paulo General Hospital:
Physical exercise
Biomarkers
Neuroprotection
ergospirometry
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders