Depressive Disorder, MajorMove4MoodNCT06398496
The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression
A study testing Aerobic Exercise in people with Depressive Disorder, Major, run by University College Cork at 1 site in Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 14 Feb 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 formal/clinical diagnosis or as determined via participant self-report i.e., bipolar spectrum disorder, schizophrenia, or psychosis, but not anxiety disorder], neurodevelopmental or neurodegenerative disorders, metabolic disorders [to include type I or II diabetes], or any condition which contraindicates, in the investigators judgement, entry to the study (including conditions which may prevent an individual from safely participating in low-to-moderate exercise intensities (57-76% heart rate max [HRmax], rating of perceived exertion [RPE]:9-13 (13))-i.e., cardiorespiratory disease[s]).
- 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- inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, or probiotics (within 1 month of starting study), anti-coagulants, thrombocyte-aggregation blocking medication(s) and over-the counter non-steroidal analgesics. Participants should have a wash-out period of four-weeks of the above-mentioned medication to be eligible for participation.
- 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.
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- 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 exercise, as assessed via the international physical activity questionnaire (IPAQ). NB: if guidelines are met from occupational or incidental physical activity, individuals would not meet exclusion criteria.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nathan D Nuzum, PhD contact
Ireland1 site, 1 recruiting
- Recruiting
University College Cork, APC Microbiome Ireland
Cork, Cork County
Move4Mood Study Recruitment, move4mood@ucc.ie
About this study
Official title: Investigating the Effects of an Exercise Intervention on Gut Bacteria, Mood and Cognition in Individuals With Major Depressive Disorder
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.
Read the detailed description
Major depressive disorder (MDD) affects 10% of people globally. Additionally, approximately only half of individuals respond to current psychotherapy treatments, with approximately 30% of individuals classed as treatment resistant to psychopharmacological treatments. Despite the current variety in treatments, the gap in efficacy of current treatments means it is imperative to develop a deeper understanding of MDD, so additional treatment options are available to help those whose current treatment is ineffective. Apart from psychotherapies or combined psychopharmacotherapies, exercise may be beneficial for individuals with MDD.
The microbiota-gut-brain-axis has been implicated in MDD, with gut bacteria relative abundance differences observed between individuals with MDD and healthy controls. Exercise interventions can reduce depressive symptoms in individuals with mild-moderate MDD and may be beneficial to people alongside standard care. Physical activity is also capable of modulating the gut microbiome. However, it remains an open question if lifestyle interventions such as exercise may act through the microbiome to enact positive outcomes in individuals with MDD.
As depression does not affect brain function exclusively, but manifests as a whole-body disorder, the investigators propose that depression is, in part, a disorder of the microbiome-gut-brain-axis. Given that the gut microbiome is capable of driving stress and immune alterations that regulate dysfunctional brain circuitry, contributing to depressive symptomology, including cognitive dysfunction and negative biases. Therefore, the current project will be the first to assess the gut microbiome in MDD, whilst undergoing an exercise intervention in conjunction with monitoring dietary intakes.
To achieve this, a RCT will be conducted with two groups of adults with MDD randomized to either a control (usual/standard care) or exercise intervention (aerobic exercise + usual/standard care). The intervention period will last 12-weeks, with those in the exercise group receiving an aerobic exercise program tailored via progressive overload to get them to meet, and then exceed the national physical activity guidelines (>150min of moderate activity per week) by the 12-week mark. Each group will be assessed pre-, mid-, and post-intervention for depressive symptoms, cognition, negative biases, along with diet information, with mechanistic insights gained from evaluation of gut microbiome composition and function, and gut metabolites in the context of microbiota-gut-brain axis signaling.
Prior to enrollment, participants will be informed about the study via a participant information leaflet, and any participant who provides written informed consent to their participation in the study, will then be screened for eligibility and enrolled if eligible.
- Conditions
- Depressive Disorder, Major
- Being tested
- Aerobic Exercise
- Keywords
- gut bacteria, exercise, cardiorespiratory fitness, negative biases
- Medical subject headings
- Depressive Disorder, Major, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Also called exercise, cardio, cardiorespiratory exercise
Aerobic exercise intervention will involve multiple exercise sessions completed (unsupervised) by participants. Exercise programs will be given to participants, matched to their current level of fitness as determined via a maximal cardiorespiratory fitness test, and will be adjusted via progressive overload every 1-2 weeks by an exercise and sports science professional.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants allocated to usual care study arm, will continue with their current treatment plan as at study enrollment. This includes any pharmacological treatment they may be receiving, as well as any psychological treatment (i.e., therapy sessions with psychiatrist, psychologist etc.). Participants in usual care group will have the same number of study visits (4 total) across a 12-week period, as the aerobic exercise group. |
| Aerobic Exercise + Usual Care | Experimental | Participants allocated to aerobic exercise study arm, will engage in aerobic exercise for 12-weeks. This will occur alongside participants usual care, as determined at study enrollment, including any pharmacological treatment they may be receiving, as well as any psychological treatment (i.e., therapy sessions with psychiatrist, psychologist etc.). Participants in aerobic exercise group will have the same number of study visits (4 total) across a 12-week period, as the usual care group. Receives: Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptom change
Depression symptoms measured via self-report questionnaire (Beck's Depression Inventory-II).
Measured: Change from baseline at 12-weeks
Negative and positive affect change
Negative and positive affect, measured via self-report positive affect negative affect schedule.
Measured: Change from baseline at 12-weeks
Gut microbiota change
Gut microbiota, measured via sequencing of stool samples (including measures of diversity, composition, and function).
Measured: Change from baseline at 12-weeks
Cognitive performance: affective perceptual bias
Emotional bias, measured via Emotional bias task via CANTAB.
Measured: Change from baseline at 12-weeks
Cognitive performance: social cognition
Emotional recognition, measured via Emotional recognition task via CANTAB.
Measured: Change from baseline at 12-weeks
Secondary outcomes (8)
Cardiorespiratory fitness change
Cardiorespiratory fitness, measured via VO2max test.
Measured: Change from baseline at 12-weeks
Cognitive performance: Psychomotor function
Reaction time, simple and multi-choice measured via CANTAB.
Measured: Change from baseline at 12-weeks
Cognitive performance: Attention
Rapid Visual Information Processing, measured via CANTAB.
Measured: Change from baseline at 12-weeks
Cognitive performance: Executive Function
Measured via One Touch stockings of Cambridge task, in CANTAB
Measured: Change from baseline at 12-weeks
Cognitive performance: Executive Function/working memory
Measured via Spatial Working Memory task, in CANTAB
Measured: Change from baseline at 12-weeks
Change in concentration of microbial and host metabolites
Assessed via untargeted metabolomics analysis
Measured: Change from baseline at 12-weeks
Change in levels of inflammatory markers
Assessed via inflammatory markers present in stimulated whole blood (including lipopolysaccharide) and unstimulated whole blood samples.
Measured: Change from baseline at 12-weeks
Change in stress symptoms
Measured via the self-report Perceived Stress Scale (PSS). Scale range is from 0-40, higher number(s) indicate higher level of perceived stress.
Measured: Change from baseline at 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start14 Feb 2024
- Primary completionMar 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to either a control (usual care only) or exercise (usual care + aerobic exercise) intervention group. 'Usual care' is whatever the participant's current treatment plan is, including pharmacological and psychological treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Clarke, PhD, Principal investigator, University College Cork, APC Microbiome Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398496
- Sponsor's protocol ID
- APC185
- Acronym
- Move4Mood
- Status last verified
- Nov 2024
- First submitted
- 1 May 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of an Exercise Intervention on Gut Bacteria, Mood and Cognition in Individuals With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06398496
- Acronym / sponsor ID
- Move4Mood / APC185
- Conditions
- Depressive Disorder, Major
- Keywords
- gut bacteria, exercise, cardiorespiratory fitness, negative biases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Major depressive disorder (MDD) affects 10% of people globally. Additionally, approximately only half of individuals respond to current psychotherapy treatments, with approximately 30% of individuals classed as treatment resistant to psychopharmacological treatments. Despite the current variety in treatments, the gap in efficacy of current treatments means it is imperative to develop a deeper understanding of MDD, so additional treatment options are available to help those whose current treatment is ineffective. Apart from psychotherapies or combined psychopharmacotherapies, exercise may be beneficial for individuals with MDD.
The microbiota-gut-brain-axis has been implicated in MDD, with gut bacteria relative abundance differences observed between individuals with MDD and healthy controls. Exercise interventions can reduce depressive symptoms in individuals with mild-moderate MDD and may be beneficial to people alongside standard care. Physical activity is also capable of modulating the gut microbiome. However, it remains an open question if lifestyle interventions such as exercise may act through the microbiome to enact positive outcomes in individuals with MDD.
As depression does not affect brain function exclusively, but manifests as a whole-body disorder, the investigators propose that depression is, in part, a disorder of the microbiome-gut-brain-axis. Given that the gut microbiome is capable of driving stress and immune alterations that regulate dysfunctional brain circuitry, contributing to depressive symptomology, including cognitive dysfunction and negative biases. Therefore, the current project will be the first to assess the gut microbiome in MDD, whilst undergoing an exercise intervention in conjunction with monitoring dietary intakes.
To achieve this, a RCT will be conducted with two groups of adults with MDD randomized to either a control (usual/standard care) or exercise intervention (aerobic exercise + usual/standard care). The intervention period will last 12-weeks, with those in the exercise group receiving an aerobic exercise program tailored via progressive overload to get them to meet, and then exceed the national physical activity guidelines (>150min of moderate activity per week) by the 12-week mark. Each group will be assessed pre-, mid-, and post-intervention for depressive symptoms, cognition, negative biases, along with diet information, with mechanistic insights gained from evaluation of gut microbiome composition and function, and gut metabolites in the context of microbiota-gut-brain axis signaling.
Prior to enrollment, participants will be informed about the study via a participant information leaflet, and any participant who provides written informed consent to their participation in the study, will then be screened for eligibility and enrolled if eligible.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomized to either a control (usual care only) or exercise (usual care + aerobic exercise) intervention group. 'Usual care' is whatever the participant's current treatment plan is, including pharmacological and psychological treatment.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants allocated to usual care study arm, will continue with their current treatment plan as at study enrollment. This includes any pharmacological treatment they may be receiving, as well as any psychological treatment (i.e., therapy sessions with psychiatrist, psychologist etc.). Participants in usual care group will have the same number of study visits (4 total) across a 12-week period, as the aerobic exercise group. |
| Aerobic Exercise + Usual Care | Experimental | Behavioral: Aerobic ExerciseParticipants allocated to aerobic exercise study arm, will engage in aerobic exercise for 12-weeks. This will occur alongside participants usual care, as determined at study enrollment, including any pharmacological treatment they may be receiving, as well as any psychological treatment (i.e., therapy sessions with psychiatrist, psychologist etc.). Participants in aerobic exercise group will have the same number of study visits (4 total) across a 12-week period, as the usual care group. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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 formal/clinical diagnosis or as determined via participant self-report i.e., bipolar spectrum disorder, schizophrenia, or psychosis, but not anxiety disorder], neurodevelopmental or neurodegenerative disorders, metabolic disorders [to include type I or II diabetes], or any condition which contraindicates, in the investigators judgement, entry to the study (including conditions which may prevent an individual from safely participating in low-to-moderate exercise intensities (57-76% heart rate max [HRmax], rating of perceived exertion [RPE]:9-13 (13))-i.e., cardiorespiratory disease[s]).
- 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- inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, or probiotics (within 1 month of starting study), anti-coagulants, thrombocyte-aggregation blocking medication(s) and over-the counter non-steroidal analgesics. Participants should have a wash-out period of four-weeks of the above-mentioned medication to be eligible for participation.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAlso: exercise, cardio, cardiorespiratory exerciseAerobic exercise intervention will involve multiple exercise sessions completed (unsupervised) by participants. Exercise programs will be given to participants, matched to their current level of fitness as determined via a maximal cardiorespiratory fitness test, and will be adjusted via progressive overload every 1-2 weeks by an exercise and sports science professional. | Behavioural | Aerobic Exercise + Usual Care |
Primary outcome
Depression symptom change
Time frame: Change from baseline at 12-weeks
Depression symptoms measured via self-report questionnaire (Beck's Depression Inventory-II).
Negative and positive affect change
Time frame: Change from baseline at 12-weeks
Negative and positive affect, measured via self-report positive affect negative affect schedule.
Gut microbiota change
Time frame: Change from baseline at 12-weeks
Gut microbiota, measured via sequencing of stool samples (including measures of diversity, composition, and function).
Cognitive performance: affective perceptual bias
Time frame: Change from baseline at 12-weeks
Emotional bias, measured via Emotional bias task via CANTAB.
Cognitive performance: social cognition
Time frame: Change from baseline at 12-weeks
Emotional recognition, measured via Emotional recognition task via CANTAB.
8 secondary outcomes
Cardiorespiratory fitness change
Time frame: Change from baseline at 12-weeks
Cognitive performance: Psychomotor function
Time frame: Change from baseline at 12-weeks
Cognitive performance: Attention
Time frame: Change from baseline at 12-weeks
Cognitive performance: Executive Function
Time frame: Change from baseline at 12-weeks
Cognitive performance: Executive Function/working memory
Time frame: Change from baseline at 12-weeks
Change in concentration of microbial and host metabolites
Time frame: Change from baseline at 12-weeks
Change in levels of inflammatory markers
Time frame: Change from baseline at 12-weeks
Change in stress symptoms
Time frame: Change from baseline at 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan D Nuzum, PhD contact
Gerard Clarke, PhD principal investigator
University College Cork, APC Microbiome Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Depressive Disorder, Major, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Move4Mood Study Recruitment ((+353) 021 4901721, move4mood@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptom change (time frame: Change from baseline at 12-weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.