Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

April 28, 2015 updated by: University of Sao Paulo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403010
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
In this group patients will not have physical exercises
ACTIVE_COMPARATOR: Physical Exercise
In this group patients will make physical exercise
Other: Physical Exercise
physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical exercise evaluation
Time Frame: One year
Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers level comparison
Time Frame: One year
To compare possible levels of cytokines, before and after controled physical exercise.
One year
Biomarkers level comparison
Time Frame: One year
To compare possible levels of markers of oxidative stress, before and after controled physical exercise.
One year
Biomarkers level comparison
Time Frame: One year
To compare possible levels of BDNF (Brain-Derived Neurotrophic Factor), before and after controled physical exercise.
One year
Biomarkers level comparison
Time Frame: One year
To compare possible levels of Cortisol, before and after controled physical exercise.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Rodrigo Machado-Vieira, Phd, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

April 27, 2015

First Posted (ESTIMATE)

April 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCLim27/FAPESP2012/20002-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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