Clinical trial NCT01899716: Exercise and Severe Depression: Clinical and Biological Analysis
Official title: Exercise and Severe Depression: Clinical and Biological Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Severe Depression
Quality of life
Exercise
BDNF
TBARS
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Depressive symptoms
timeFrame: 2 weeks of hospitalization (14 days)
Secondary outcomes:
measure: Quality of Life
timeFrame: 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)
measure: Brain-Derived Neurotrophic Factor(BDNF)
timeFrame: 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)
measure: Thiobarbituric acid reactive substances(TBARS)
timeFrame: 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)
measure: Depressive symptoms at discharge (participants will be followed for the duration of hospital stay, an expected average of 3 weeks)
timeFrame: Discharge
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clincas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: HCPA
name: Felipe B Schuch, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: HCPA
name: Marcelo PA Fleck, PhD
role: STUDY_DIRECTOR
References:
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.
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.