Major Depressive Disorder (MDD)NCT06990035
Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
A study testing Mediterranean diet lessons program and Physical activity in people with Major Depressive Disorder (MDD), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 2 sites in Italy.
Trial summary
This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Mediterranean diet lessons program and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Jan 2026to Aug 2027
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).
- Depressive symptoms assessed using MADR, BDI, or ZDR scales.
- Ability to provide written informed consent.
- Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.
Who cannot join
- Patients with severe psychopathology.
- Medical contraindications to physical activity.
- Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.
- Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months
- Active gastrointestinal diseases
- Autoimmune and/or chronic inflammatory disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Centro San Giovanni fi Dio Fatebenefratelli
Brescia, Italy, 25125
Annamaria Cattaneo, PhD, 030 3501599, acattaneo@fatebenefratelli.eu
- Recruiting
Comunità Fraternità società cooperativa sociale ONLUS
Ospitaletto, Italy, 25035
Ezio Cigognetti, +393318619915, ecigo@inwind.it
About this study
Official title: Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato
This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention.
Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Mediterranean diet lessons program, Physical activity
- Keywords
- Major depressive disorder, Physical activity, Mediterranean Diet, Microbiome
- 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.
Mediterranean diet lessons programBehavioural
Participants will attend five one-hour lessons delivered by qualified professionals to learn about foods that have a positive impact on cognitive function and how to incorporate them into their dietary regimen.
Physical activityBehavioural
Participants will undergo a 12-week physical exercise program guided by specified personal trainers.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Mediterranean diet lessons program Receives: Behavioral: Mediterranean diet lessons program |
| Experimental Group | Experimental | Physical activity program Receives: Behavioral: Mediterranean diet lessons program; Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADR Scale for Depression
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome.
Measured: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
Beck Depression Inventory - II
The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. It comprises 21 items, each rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Measured: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
Zung Self-Rating Depression Scale
The Zung Self-Rating Depression Scale (ZRS) is a self-administered questionnaire designed to assess the level of depressive symptoms in individuals. It consists of 20 items, each rated on a scale from 1 to 4, based on how often symptoms are experienced. The raw total score ranges from 20 to 80, which is often converted to an index score (ranging from 25 to 100) by multiplying the raw score by 1.25. Higher scores indicate more severe depression
Measured: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
Personal and Social Performance Scale
The Personal and Social Performance Scale (PSP) is a clinician-rated instrument used to assess personal and social functioning in individuals with mental disorders. The total score ranges from 1 to 100, with higher scores indicating better functioning and a more favorable clinical outcome.
Measured: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
World Health Organization Quality of Life - Bref
The WHOQOL-BREF is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.
Measured: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
Secondary outcomes (2)
Immunitary-related factors levels
Plasma/serum levels of cytokines
Measured: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
Gut Microbiome Composition
Measured: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start26 Jan 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Comunità Fraternità società cooperativa sociale ONLUS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990035
- Sponsor's protocol ID
- 5M-2022-23685026
- Status last verified
- Oct 2026
- First submitted
- 29 Apr 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato
- ClinicalTrials.gov ID
- NCT06990035
- Acronym / sponsor ID
- 5M-2022-23685026
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major depressive disorder, Physical activity, Mediterranean Diet, Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- Comunità Fraternità società cooperativa sociale ONLUS
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 May 2025 (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 clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention.
Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Mediterranean diet lessons programMediterranean diet lessons program |
| Experimental Group | Experimental | Behavioral: Mediterranean diet lessons program, Behavioral: Physical activityPhysical activity program |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).
- Depressive symptoms assessed using MADR, BDI, or ZDR scales.
- Ability to provide written informed consent.
- Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.
Key exclusion criteria (6 listed)
- Patients with severe psychopathology.
- Medical contraindications to physical activity.
- Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.
- Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months
- Active gastrointestinal diseases
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 |
|---|---|---|
| Mediterranean diet lessons programParticipants will attend five one-hour lessons delivered by qualified professionals to learn about foods that have a positive impact on cognitive function and how to incorporate them into their dietary regimen. | Behavioural | Control Group, Experimental Group |
| Physical activityParticipants will undergo a 12-week physical exercise program guided by specified personal trainers. | Behavioural | Experimental Group |
Primary outcome
MADR Scale for Depression
Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered scale designed to assess the severity of depressive symptoms. It consists of 10 items, each rated on a scale from 0 to 6, yielding a total score ranging from 0 to 60. Higher scores indicate greater severity of depression, meaning a worse clinical outcome.
Beck Depression Inventory - II
Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
The Beck Depression Inventory (BDI) is a self-report questionnaire used to assess the presence and severity of depressive symptoms. It comprises 21 items, each rated on a scale from 0 to 3, resulting in a total score ranging from 0 to 63. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Zung Self-Rating Depression Scale
Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
The Zung Self-Rating Depression Scale (ZRS) is a self-administered questionnaire designed to assess the level of depressive symptoms in individuals. It consists of 20 items, each rated on a scale from 1 to 4, based on how often symptoms are experienced. The raw total score ranges from 20 to 80, which is often converted to an index score (ranging from 25 to 100) by multiplying the raw score by 1.25. Higher scores indicate more severe depression
Personal and Social Performance Scale
Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
The Personal and Social Performance Scale (PSP) is a clinician-rated instrument used to assess personal and social functioning in individuals with mental disorders. The total score ranges from 1 to 100, with higher scores indicating better functioning and a more favorable clinical outcome.
World Health Organization Quality of Life - Bref
Time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
The WHOQOL-BREF is a self-report questionnaire developed by the WHO to assess quality of life across multiple domains. It contains 26 items rated on a 5-point Likert scale. Higher scores indicate a better quality of life, reflecting a more favorable outcome.
2 secondary outcomes
Immunitary-related factors levels
Time frame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
Gut Microbiome Composition
Time frame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
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 27 Oct 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet lessons program and Physical activity in people with Major Depressive Disorder (MDD), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 2 sites in Italy.
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 6 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Annamaria Cattaneo, PhD (0039 030 3501599, acattaneo@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADR Scale for Depression (time frame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).). 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 27 Oct 2026.