Exercise and Severe Depression: Clinical and Biological Analysis

Depression Clinical Trial

Official title:

Exercise and Severe Depression: Clinical and Biological Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899716
• Other study ID #: 07-438
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: December 27, 2013
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Brazil	Hospital de Clincas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms	Hamilton 17 for depression	2 weeks of hospitalization (14 days)	No
Secondary	Quality of Life	WHOQOL-BREF	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)	No
Secondary	Brain-Derived Neurotrophic Factor(BDNF)		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)	No
Secondary	Thiobarbituric acid reactive substances(TBARS)		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)	No
Secondary	Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)	Hamilton Scores at discharge	Discharge	No