Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms in Depressive Disorders

Launched by FUNDACIÓN DE INVESTIGACIÓN BIOMÉDICA - HOSPITAL UNIVERSITARIO DE LA PRINCESA · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how physical exercise can help people with Major Depressive Disorder (MDD). Researchers want to understand the effects of exercise on depression and learn about the biological changes that might happen when someone exercises. They will compare two groups: one group will follow their regular treatment with antidepressants and also participate in an exercise program, while the other group will just continue with their usual treatment without adding any exercise.

To be part of this study, participants must be diagnosed with MDD and have moderate depression symptoms. They should also be receiving antidepressant treatment but must not have other major mental health issues or certain physical conditions that would prevent them from participating. Over 12 weeks, participants in the exercise group will engage in physical activities designed to see if exercise can significantly improve their mood. This study is not yet recruiting, but it aims to find out if exercise can be a helpful addition to traditional treatments for depression.

Gender

ALL

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.