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New treatment option for Depressive Disorder, Major
Official title The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression
ClinicalTrials.gov ID: NCT06398496
What this study is testing
- What it's testing
- This study aims to investigate the effects of a 12-week aerobic (cardio) exercise intervention in people with Major Depressive Disorder. Measurements taken before, during, and following the 12-week intervention will include assessments of cognition, cardiorespiratory fitness, stress, mood and emotion, and gut bacteria.
- 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 59
You may be able to join if
- Be able to give written informed consent.
- Be between 18 and 59 years of age.
- Be in generally good health as determined by the investigator (excluding Major Depressive Disorder diagnosis).
- Community dwelling with a current diagnosis of Major Depressive Disorder, and current depression episode/symptoms as determined via Beck's depression...
You likely can't join if
- Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment).
- Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal (GI) [including functional GI disorders, inflammatory bowel...
- Have a malignant disease or any concomitant end-stage organ disease.
- Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or...
- Individuals who are considered to be poor attendees, in the opinion of the investigator, or unlikely for any reason to be able to comply with the...
- Participants must not be currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial...
See the full eligibility criteria
- Be able to give written informed consent.
- Be between 18 and 59 years of age.
- Be in generally good health as determined by the investigator (excluding Major Depressive Disorder diagnosis).
- Community dwelling with a current diagnosis of Major Depressive Disorder, and current depression episode/symptoms as determined via Beck's depression inventory-II (score 13-31).
- Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment).
- Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal (GI) [including functional GI disorders, inflammatory bowel disease, coeliac disease], immunological, psychiatric [to include...
- Have a malignant disease or any concomitant end-stage organ disease.
- Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; to include anti-...
- Individuals who are considered to be poor attendees, in the opinion of the investigator, or unlikely for any reason to be able to comply with the trial.
- Participants must not be currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
- Are meeting the national physical activity guidelines (16) (i.e., at least 30 minutes a day of moderate intensity activity, five days a week (or 150 minutes a week), specifically in relation to structured aerobic...
- Current perimenopause, menopause, or post-menopause, in the case of females.
- Females who are pregnant, planning a pregnancy within duration of the study intervention period, or currently lactating.
- Participants who are not fluent in English or English is not first language.
- Are colour blind.
- Have dyslexia or dyscalculia.
- Are a current habitual daily smoker.
- Regular, illegal drug use.
- Alcohol abuse disorder.
- Acute suicidality or suicide attempt in the past 6 months.
- Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder).
The study team makes the final eligibility decision.
Where it's taking place
- Cork, Cork County, Ireland
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cork, Cork County, Ireland. 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.