Effectiveness of Exercise in the Treatment of Depression

Depression Clinical Trial

— DEP-EXERCISE  

Official title:

Effectiveness of Exercise in the Treatment of Depression in Older People as an Alternative to Drugs Antidepressants in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03358433
• Other study ID #: PI15/01486
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: November 25, 2017
• Start date: June 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: Gerencia de Atención Primaria, Albacete
• Contact: Jesús López-Torres Hidalgo, MD
• Phone: +34653137665
• Email: jesusl[@]sescam.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective is to test the non-inferiority of supervised exercise versus antidepressant treatment in reducing depressive symptoms in patients with clinical criteria for depression (according to ICD 10) over a period of 6 months follow-up.

Description:

This is a randomized clinical trial in primary care in which a total of 312 patients over 65 years with clinically significant depression will be randomly assigned to an exercise program supervised or receive treatment with antidepressant drugs commonly used in clinical practice. At baseline physical fitness of the participants will be checked, and assessments will be made after 15 days and 1, 3 and 6 months. The supervised exercise program will consist of 2 sessions per week in groups of 10-12 patients over a 6 month period in which a sports instructor will train patients to perform at least 30 minutes of regular, moderate-intensity activity with a frequency almost daily, including aerobic exercise and strength training, flexibility and balance. In both groups will be evaluated periodically, among other variables, the state of depressive symptoms, level of physical activity, self-rated health, occurrence of adverse effects and adherence to exercise program or antidepressant treatment. The main outcome measure is the reduction of the baseline score on the scales of depressive symptoms (Montgomery-Asberg Depression Rating Scale and Geriatric Depression Scale).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: December 31, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• People with depression

Exclusion Criteria:

• Contraindication to exercise

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Exercise
• Primary Care

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Spain	Jesús López-Torres Hidalgo	Albacete

Sponsors (1)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Albacete

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in depressive symptoms		6 months