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Exercise and Severe Depression: Clinical and Biological Analysis

Primary Purpose

Depression

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Depression focused on measuring Severe Depression, Quality of life, Exercise, BDNF, TBARS

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Major Depressive Disorder according to M.I.N.I (DSM-IV) criteria American Psychiatry Association(1994)
score of 25 or more on Hamilton-17
not being involved in other physical activity programs during the hospitalization
aged between 18 and 60 years
being able to read, understand, and provide written informed consent

Exclusion Criteria:

have three or more cardiovascular risk factors according to Physical Activity Readiness Questionnaire (PAR-Q)
are unable to exercise due other clinical condition
have diagnosis of Schizophrenia, Bipolar disorder or current use of alcohol or other drugs according to M.I.N.I DSM-IV criteria American Psychiatry Association(1994)
if they are taking beta-blocking medications

Sites / Locations

Hospital de Clincas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week.

Outcomes

Primary Outcome Measures

Depressive symptoms

Hamilton 17 for depression

Secondary Outcome Measures

Quality of Life

WHOQOL-BREF

Brain-Derived Neurotrophic Factor(BDNF)

Thiobarbituric acid reactive substances(TBARS)

Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Hamilton Scores at discharge

Full Information

NCT ID

NCT01899716

First Posted

June 13, 2013

Last Updated

December 27, 2013

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT01899716

Brief Title

Exercise and Severe Depression: Clinical and Biological Analysis

Official Title

Exercise and Severe Depression: Clinical and Biological Analysis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

Brief Summary

The study aimed to evaluate the use of exercise as a complementary strategy to treat severe major depression in inpatients. Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe depressed inpatients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Severe Depression, Quality of life, Exercise, BDNF, TBARS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Aerobic Exercise, 3 times peer week, A dose of 16.5 kcal/kg weight peer week.

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Exercise

Other Intervention Name(s)

Aerobic Exercise

Primary Outcome Measure Information:

Title

Depressive symptoms

Description

Hamilton 17 for depression

Time Frame

2 weeks of hospitalization (14 days)

Secondary Outcome Measure Information:

Title

Quality of Life

Description

WHOQOL-BREF

Time Frame

Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Title

Brain-Derived Neurotrophic Factor(BDNF)

Time Frame

Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Title

Thiobarbituric acid reactive substances(TBARS)

Time Frame

Baseline, after 2 weeks of hospitalization and at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Title

Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)

Description

Hamilton Scores at discharge

Time Frame

Discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Major Depressive Disorder according to M.I.N.I (DSM-IV) criteria American Psychiatry Association(1994) score of 25 or more on Hamilton-17 not being involved in other physical activity programs during the hospitalization aged between 18 and 60 years being able to read, understand, and provide written informed consent Exclusion Criteria: have three or more cardiovascular risk factors according to Physical Activity Readiness Questionnaire (PAR-Q) are unable to exercise due other clinical condition have diagnosis of Schizophrenia, Bipolar disorder or current use of alcohol or other drugs according to M.I.N.I DSM-IV criteria American Psychiatry Association(1994) if they are taking beta-blocking medications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felipe B Schuch, MSc

Organizational Affiliation

HCPA

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marcelo PA Fleck, PhD

Organizational Affiliation

HCPA

Official's Role

Study Director

Facility Information:

Facility Name

Hospital de Clincas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035-903

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

21616540

Citation

Schuch FB, Vasconcelos-Moreno MP, Borowsky C, Fleck MP. Exercise and severe depression: preliminary results of an add-on study. J Affect Disord. 2011 Oct;133(3):615-8. doi: 10.1016/j.jad.2011.04.030. Epub 2011 May 25.

Results Reference

result

PubMed Identifier

23565097

Citation

Schuch FB, de Almeida Fleck MP. Is Exercise an Efficacious Treatment for Depression? A Comment upon Recent Negative Findings. Front Psychiatry. 2013 Apr 2;4:20. doi: 10.3389/fpsyt.2013.00020. eCollection 2013. No abstract available.

Results Reference

result

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Exercise and Severe Depression: Clinical and Biological Analysis

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