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New treatment option for Major Depressive Disorder
Official title Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders
ClinicalTrials.gov ID: NCT06450704
What this study is testing
What is Antidepressant medication (ADM)?
Antidepressant medication (ADM) is an investigational medicine, given as an once-weekly, being studied as a potential treatment for major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Alcalá de Henares, Madrid, Spain
- Madrid, Madrid, Spain
- Majadahonda, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alcalá de Henares, Madrid, Spain; Madrid, Madrid, Spain; Majadahonda, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.