NCT03358433

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 25, 2017

Last Update Submit

November 25, 2017

Conditions

DepressionPrimary CareExercise

Outcome Measures

Primary Outcomes (1)

  • Improvement in depressive symptoms

    6 months

Study Arms (2)

Exercise

EXPERIMENTAL
Other: Exercise

Antidepressants

ACTIVE COMPARATOR
Other: Exercise

Interventions

ExerciseOTHER
Also known as: Antidepressants
AntidepressantsExercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • People with depression

You may not qualify if:

  • Contraindication to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jesús López-Torres Hidalgo

Albacete, 02006, Spain

RECRUITING

Unknown Facility

Albacete, Spain

RECRUITING

Related Publications (2)

  • Hidalgo JL, Sotos JR; DEP-EXERCISE Group. Effectiveness of Physical Exercise in Older Adults With Mild to Moderate Depression. Ann Fam Med. 2021 Jul-Aug;19(4):302-309. doi: 10.1370/afm.2670.

    PMID: 34264835DERIVED

  • Lopez-Torres Hidalgo J; DEP-EXERCISE Group. Effectiveness of physical exercise in the treatment of depression in older adults as an alternative to antidepressant drugs in primary care. BMC Psychiatry. 2019 Jan 14;19(1):21. doi: 10.1186/s12888-018-1982-6.

    PMID: 30642326DERIVED

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

ExerciseAntidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPsychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Jesús López-Torres Hidalgo, MD

    Centro de Salud Zona VIII de Albacete (Spain)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesús López-Torres Hidalgo, MD

CONTACT

+34653137665jesusl@sescam.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 25, 2017

First Posted

November 30, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

December 31, 2018

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

ES(2)