Major Depressive Disorder Clinical Trial
— CARE-MINDOfficial title:
Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical Trial.
The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are: - What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise? - How effective is a physical exercise program in MDD patients in real-life conditions? The experimental group will receive an exercise intervention as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). Researchers will compare to a control group, which will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity. The aim is to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.
Status | Not yet recruiting |
Enrollment | 124 |
Est. completion date | December 31, 2026 |
Est. primary completion date | September 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de La Princesa | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Príncipe de Asturias | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid |
Lead Sponsor | Collaborator |
---|---|
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Centro de Investigación Biomédica en Red de Salud Mental, Hospital Universitario La Paz, Hospital Universitario Principe de Asturias, Hospital Universitario Ramon y Cajal, Quirón Madrid University Hospital, Universidad Autonoma de Madrid |
Spain,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory and oxidative stress biomarkers | Nrf2 activity will be measured in circulating monocytes and through transcriptomic analysis of redox and inflammation related genes. Plasma levels of hs C-reactive protein (CRP), interleukin 6 (hs-IL-6) and tumoral nechrosis factor alfa (hs- TNF-alfa) will be analyzed. | 1. Before randomization; 2. 12-weeks after the beggining of intervention; 3. 1 year after randomization | |
Primary | Brain imaging | It will be evaluated using Magnetic Resonance Imaging. Four different sequences will be acquired: a) a T2-FLAIR sequence; b) a 3D T1w MPRAGE sequence; c) a Diffusion Weighted sequence and d) a T2 resting-state sequence. These data will be used to discard any neurological issues, to evaluate structural changes, and for other images coregistration, to evaluate the integrity of white matter and structural connectivity, and to evaluate functional connectivity. | 1. Before randomization; 2. 12 Weeks after the beggining of intervention | |
Primary | Clinical evaluation | The change in depression symptoms will be measured with the HAM-D17 scale. Duration of illness, number of episodes, current treatments, resistance antidepressant treatment index (Thase) will also be assessed. | 1. Before Randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Primary | 24-hours activity behaviors | Physical activity, sedentarism and sleep will be objectively measured using a multi-sensor monitor (ActiGraph GT9X Link, Pensacola, FL, USA) over a 24-hour 7 days period at the onset of the exercise intervention and 7 days post-intervention. Only participants who carry the monitor for at least 95% of the day (1368 minutes) will be included in the analysis. This monitor is worn as a watch and will be placed on the non-dominant wrist. Daily steps will be recorded through the activity band (MiBand6). | 1. Onset of the intervention; 2. 7 Days after intervention | |
Primary | Physical activity information | It will be assessed through the European Prospective Investigation into Cancer and Nutrition physical activity questionnaire (EPIC). | 1. Before Randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Cognitive evaluation | Learning and verbal memory through the Hopkins Verbal Learning Test-Revised (HVLT-R); executive functioning through the Trail Making Test part B (TMT-B) and the short form of the Wisconsin Card Sorting Test (WCST-64); processing speed through the Salthouse Perceptual Comparison Test (SPCT). | 1. Before Randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Functioning and Well-Being | The patient's functioning will be assessed through the WHO-DAS-II and well-being will be measured with the Cantrill ladder. | 1. Before randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Muscle strength | It will be directly measured through a handheld dynamometer (TKK 5401 Grip-D, Takey, Tokyo, Japan) and a dynamometer for the upper and lower extremities (Lafayette Instruments dynamometer, Lafayette, Ind). | 1. Before randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Cardiorespiratory fitness | It will be measured with an established test protocol on a bicycle ergometer. During a ramp protocol workload increases of 1 W every 6 s will be applied starting from an initial load of 0 W, with a pedal cadence of 60 -70 rpm throughout the test. | 1. Before randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Anthropometric evaluation | Weight will be assessed through a stadiometer (SECA) and waist circumference with a metric tape (Harpenden anthropometric tape, Holtain Ltd). Body Mass Index, waist-to-hip ratio and blood pressure also will be assessed. | 1. Before randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Metabolic biomarkers | Serum levels of glucose, glycosylated haemoglobin and lipid profile. | 1. Before randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization | |
Secondary | Nutrition habits | It will be assessed with the Food Frequency Questionnaire (FFQ). | 1. Before randomization; 2. 12 Weeks after the beggining of intervention; 3. 1 Year after randomization |
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