Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

NCT ID: NCT02427789

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

In this group patients will not have physical exercises

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical Exercise

In this group patients will make physical exercise

Group Type: ACTIVE_COMPARATOR

Physical Exercise

Intervention Type: OTHER

physical exercise

Interventions

Physical Exercise

physical exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodrigo Machado-Vieira, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 27152523 (View on PubMed)

Other Identifiers

HCLim27/FAPESP2012/20002-5

Identifier Type: -

Identifier Source: org_study_id