Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Major Depressive Disorder Clinical Trial

Official title:

Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427789
• Other study ID #: HCLim27/FAPESP2012/20002-5
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: April 28, 2015
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Physical Exercise
physical exercise

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical exercise evaluation	Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.	One year	No
Secondary	Biomarkers level comparison	To compare possible levels of cytokines, before and after controled physical exercise.	One year	No
Secondary	Biomarkers level comparison	To compare possible levels of markers of oxidative stress, before and after controled physical exercise.	One year	No
Secondary	Biomarkers level comparison	To compare possible levels of BDNF (Brain-Derived Neurotrophic Factor), before and after controled physical exercise.	One year	No
Secondary	Biomarkers level comparison	To compare possible levels of Cortisol, before and after controled physical exercise.	One year	No