Clinical trial NCT02427789: Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Official title: Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Physical exercise
Biomarkers
Neuroprotection
ergospirometry
Major Depressive Disorder
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Physical exercise evaluation
timeFrame: One year
Secondary outcomes:
measure: Biomarkers level comparison
timeFrame: One year
measure: Biomarkers level comparison
timeFrame: One year
measure: Biomarkers level comparison
timeFrame: One year
measure: Biomarkers level comparison
timeFrame: One year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Rodrigo Machado-Vieira, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siqueira CC, Valiengo LL, Carvalho AF, Santos-Silva PR, Missio G, de Sousa RT, Di Natale G, Gattaz WF, Moreno RA, Machado-Vieira R. Antidepressant Efficacy of Adjunctive Aerobic Activity and Associated Biomarkers in Major Depression: A 4-Week, Randomized, Single-Blind, Controlled Clinical Trial. PLoS One. 2016 May 6;11(5):e0154195. doi: 10.1371/journal.pone.0154195. eCollection 2016.