Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT06450704
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria (through the Mini International Neuropsychiatric Interview (MINI)
* Severity of depression according to the Hamilton Depression Rating Scale 17 items (Ham-D17): minimum of 14 cut-off score of moderate depression.
* Outpatient clinical care.
* Current antidepressant treatment that will be maintained during the 12 weeks of the physical exercise intervention.
Exclusion Criteria:
* Diagnosis of any axis I diagnosis except for MDD;
* Contraindications for Magnetic Resonance Imaging.
* Antiinflammatory treatments or antibiotics within the week before randomisation.
* Vaccines within the month before randomisation.
* Fever (\>38ºC) at the moment of study entry.
* Pregnant women.
* Alcohol or drug abuse; Ongoing alcohol use and drug use will be assessed through the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Abuse Screening Test (DAST-10) respectively since it may affect inflammation.
* Excessive physical exercise assessed through certain questions extracted from the European Prospective Investigation into Cancer and Nutrition Physical Activity questionnaire.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06450704
Study Brief:
Protocol Section:
NCT06450704