Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Physical exercise, Biomarkers, Neuroprotection, ergospirometry, Major Depressive Disorder
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
Sites / Locations
- University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Physical Exercise
Arm Description
In this group patients will not have physical exercises
In this group patients will make physical exercise
Outcomes
Primary Outcome Measures
Physical exercise evaluation
Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.
Secondary Outcome Measures
Biomarkers level comparison
To compare possible levels of cytokines, before and after controled physical exercise.
Biomarkers level comparison
To compare possible levels of markers of oxidative stress, before and after controled physical exercise.
Biomarkers level comparison
To compare possible levels of BDNF (Brain-Derived Neurotrophic Factor), before and after controled physical exercise.
Biomarkers level comparison
To compare possible levels of Cortisol, before and after controled physical exercise.
Full Information
NCT ID
NCT02427789
First Posted
January 24, 2014
Last Updated
April 28, 2015
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02427789
Brief Title
Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Official Title
Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Physical exercise, Biomarkers, Neuroprotection, ergospirometry, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group patients will not have physical exercises
Arm Title
Physical Exercise
Arm Type
Active Comparator
Arm Description
In this group patients will make physical exercise
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
physical exercise
Primary Outcome Measure Information:
Title
Physical exercise evaluation
Description
Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Biomarkers level comparison
Description
To compare possible levels of cytokines, before and after controled physical exercise.
Time Frame
One year
Title
Biomarkers level comparison
Description
To compare possible levels of markers of oxidative stress, before and after controled physical exercise.
Time Frame
One year
Title
Biomarkers level comparison
Description
To compare possible levels of BDNF (Brain-Derived Neurotrophic Factor), before and after controled physical exercise.
Time Frame
One year
Title
Biomarkers level comparison
Description
To compare possible levels of Cortisol, before and after controled physical exercise.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Machado-Vieira, Phd
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
ZIP/Postal Code
05403010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27152523
Citation
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.
Results Reference
derived
Learn more about this trial
Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression
We'll reach out to this number within 24 hrs