Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Other: Physical Exercise

• Registration Number: NCT02427789
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2013-01
• Study First Submitted: 2014-01-24
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Exercise	Physical Exercise	In this group patients will make physical exercise

Primary Outcome Measures

Name	Time	Method
Physical exercise evaluation	One year	Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.

Secondary Outcome Measures

Name	Time	Method
Biomarkers level comparison	One year	To compare possible levels of Cortisol, before and after controled physical exercise.

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 São Paulo, Brazil