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Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427789
Enrollment
40
Registered
2015-04-28
Start date
2012-03-31
Completion date
2014-07-31
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Physical exercise, Biomarkers, Neuroprotection, ergospirometry, Major Depressive Disorder

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.

Interventions

OTHERPhysical Exercise

physical exercise

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical exercise evaluationOne yearEvaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.

Secondary

MeasureTime frameDescription
Biomarkers level comparisonOne yearTo compare possible levels of cytokines, before and after controled physical exercise.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026