NCT02427789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
Last Updated

April 29, 2015

Status Verified

January 1, 2013

Enrollment Period

2.1 years

First QC Date

January 24, 2014

Last Update Submit

April 28, 2015

Conditions

Major Depressive Disorder

Keywords

Physical exerciseBiomarkersNeuroprotectionergospirometryMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Physical exercise evaluation

    Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.

    One year

Secondary Outcomes (4)

  • Biomarkers level comparison

    One year

  • Biomarkers level comparison

    One year

  • Biomarkers level comparison

    One year

  • Biomarkers level comparison

    One year

Study Arms (2)

Control

NO INTERVENTION

In this group patients will not have physical exercises

Physical Exercise

ACTIVE COMPARATOR

In this group patients will make physical exercise

Other: Physical Exercise

Interventions

Physical ExerciseOTHER

physical exercise

Physical Exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unstable Clinical Diseases
  • Patients Unable to make Physical Exercises
  • Present frequencies below 90% attendance in the program aerobic fitness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 27152523DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rodrigo Machado-Vieira, Phd

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

April 28, 2015

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

April 29, 2015

Record last verified: 2013-01

Locations

BR(1)