Major Depressive DisorderLeakyBraInCSNCT05950009
Relationship Between Major Depression and Periodontal Diseases
An observational study of Major Depressive Disorder and Periodontitis, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial summary
Background: There are epidemiological and preclinical studies in vivo that support the biological plausibility of the association between periodontal diseases and major depression (DM), through the hypothesis of a "leaky mouth" by periodontitis as a source of neuroinflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Periodontitis
- How many people
- 122 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Feb 2024to Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects in the case group - MD group- will be selected from those patients seen at the Outpatient Clinic of Institute of Psychiatry and Mental Health of Hospital Clínico San Carlos. Subjects in the control group - Non MD group- will be recruited from the control group of a population-based study PsicoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E) that is currently being performed by the lab of JCL. They will be matched on age, gender, and socio-economic status. In order to confirm that they are in good mental health, they will receive a pre-screen, online questionnaire to screen for symptoms of anxiety and depression (PHQ-9, STAI).
Who may be able to join
- Age greater or equal to 18 years.
- For the case group (MD patients), subjects with moderate or severe major depression, without severe suicide ideation, as characterized by the Patient Health Questionnaire (PHQ)-9 index (values of 9 or greater) and by the Structured Clinical Interview for DSM-5 - (SCID) will be selected.
- For the control group, subjects without mental health pathologies identified by SCID, who present an PHQ-9 index of 5 or below will be included as controls.
Who cannot join
- Pregnant or breastfeeding women.
- Diabetes mellitus.
- Chronic conditions: HIV infection, chronic intake of NSAIDs.
- Comorbidity with other mental disorders: eating disorders, borderline personality disorders, bipolar disorders, schizophrenia and related disorders, and/or any mental serious disease other than major depression.
- Severe suicide ideation.
- Patients who had received periodontal treatment for periodontitis in the last year.
Show all 9Show fewer
- Presence of necrotizing periodontal diseases.
- Presence of less than three teeth per quadrant.
- Antibiotic use in the last 6 months prior to the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry, University Complutense of Madrid (UCM)
Madrid, 28034
Elena Figuero Ruiz, 646831548, efigueruiz@gmail.com
Juan Carlos Leza Cerro, 0034913941478, jcleza@ucm.es
- Recruiting
Instituto de Psiquiatría y Salud Mental, Hospital Clínico San Carlos
Madrid, 28040
David Fraguas, davidfraguas@gmail.com
About this study
Official title: Relationship Between Major Depression and Periodontal Diseases: Analytical Cross-sectional Study
Background: There are epidemiological and preclinical studies in vivo that support the biological plausibility of the association between periodontal diseases and major depression (DM), through the hypothesis of a "leaky mouth" by periodontitis as a source of neuroinflammation. Therefore, this association should be studied in depth in carefully designed cross-sectional studies in humans to specifically assess this relationship.
Objectives: Primary: determine if periodontitis can be associated with the development of DM. Secondary: (1) to estimate the prevalence of periodontal diseases (gingivitis and periodontitis) in patients with and without DM; (2) to determine whether oral, periodontal, and fecal (bacterial, viral, and fungal) metagenomic microbiomes, inflammatory mediators, and intestinal barrier integrity are associated with periodontal and mental health variables.
Read more
Material and method:
A cross-sectional analytical study with two groups is designed:
- Control group (without DM): subjects without known mental health pathologies will be included, who present a PHQ-9 index of 5 or less. They will be recruited from the control group of a population-based study PsychoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E). They will be matched by age, gender, and socioeconomic status.
- Group of cases (MD patients): subjects with moderate DM will be selected, characterized by HPQ9 index values of 9 or higher. They will be selected among those patients who attend the Mental Health consultations associated with the San Carlos Clinical Hospital.
The study will consist of three visits:
- Visit in Mental Health Consultations: in this visit the subject will be evaluated to determine if he meets the eligibility criteria. You will be informed of the purpose of the study and you will be invited to participate and sign the informed consent. After that, a structured clinical interview for the DSM-IV (SCID) will be conducted and the subject will fill in a series of specific scales on a study-specific electronic device [Beck Depression Inventory (BDI); UCLA Loneliness Scale, Center for Epidemiologic Studies Depression scale [CES-D]; Childhood Trauma Questionnaire short form (CTQ-SF); The World Health Organization Quality of Life questionnaire (WHOQOL); Hamilton scale (HAM-D17); Global Assessment of Functioning (GAF) Scale].
- Dental School Visit: Subject will receive a comprehensive periodontal examination. A subgingival microbiological sample, a saliva sample and a blood sample will also be taken. The patient will be given a specific vial to collect stool samples.
- At the participant's home: the stool samples will be deposited by the participants at home in the specific collection vial.
- Conditions
- Major Depressive Disorder, Periodontitis
- Being tested
- No intervention (observational studies)
- Medical subject headings
- Depressive Disorder, Major, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational studies)Other
No intervention (observational studies)
| Study group | Role | What they receive |
|---|---|---|
| Cases _major depression patients | subjects with moderate or severe major depression, without severe suicide ideation, as characterized by the Patient Health Questionnaire (PHQ)-9 index (values of 9 or greater) and by the Structured Clinical Interview for DSM-5 - (SCID) will be selected. Receives: Other: No intervention (observational studies) | |
| Controls | subjects without mental health pathologies identified by SCID, who present an PHQ-9 index of 5 or below will be included as controls. Receives: Other: No intervention (observational studies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontitis (presence/absence)
With the clinical and radiological information, the periodontal diagnosis of the patients will be established according to the 2018 classification of periodontal and peri-implant diseases), which involves determining the stage (I to IV), the extent of the stage (localized, generalized or incisor-molar pattern) and the grade (A, B or C).
Measured: Baseline
Secondary outcomes (11)
Childhood Trauma Questionnaire short form (CTQ-SF)
Range: 25 to 125. A higher score means more (and worst) traumatic experience.
Measured: Baseline
UCLA Loneliness Scale (Spanish version)
Range: 20 to 80. Higher scores indicatehigher levels of loneliness
Measured: Baseline
The World Health Organization Quality of Life questionnaire (WHOQOL)
Range: 0 to100. A higher score means better quality of life.
Measured: Baseline
Beck Depression Inventory (BDI)
Range: 0 to 63. A higher score means more severe-depressive symptomatology
Measured: Baseline
Centre for Epidemiologic Studies Depression scale [CES-D]
Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology
Measured: Baseline
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severe the depressive symptoms
Measured: Baseline
Global Assessment of Functioning (GAF) Scale.
Range: 1 to 100. A higher score means better functioning. A score of 0 means Inadequate information.
Measured: Baseline
Subgingival microbiota
Bacterial DNA extraction will be performed using a commercial kit (Molzym Gmbh\& Co.KG; Bremen, Germany) specific for bacterial DNA extraction. DNA samples will be frozen at -80°C and preserved until further analysis by quantitative polymerase chain reaction (q-PCR) (Marin et al., 2019) and 16S rRNA sequencing, using the Illumina MiSeq platform. The analysis of sequences obtained for the microbiome will include: a) quality control and trimming: PCR primers, chimeric sequences, and short and low-quality reads will be discarded; b) mapping: annotation at different taxonomic levels; c) rarefaction curves; d) quantification: counts and percentages of the presence of specific bacteria in each sample at different taxonomic levels; e) calculation of the biodiversity index and f) comparison between samples. The analysis by q-PCR will include the detection and quantification of the most prevalent or abundant species.
Measured: Baseline
Plasma levels of inflammatory mediators
plasma levels of inflammatory mediators IL-1β, TNF-α, IL-6, prostaglandin E2 and CPRhs
Measured: Baseline
Saliva microbiota
microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences are compared to phylogenetic and functional databases to obtain taxonomic and functional profiles
Measured: Baseline
Gut microbiota (Stool samples)
microbial DNA will be used for library preparation and metagenomic shotgun sequencing using the Illumina HiSeq 2500 System. Shotgun metagenomic sequencing can identify bacteria, fungi, and viruses, with a resolution that allows species-level identification. Sequences are compared to phylogenetic and functional databases to obtain taxonomic and functional profiles
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start20 Feb 2024
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950009
- Sponsor's protocol ID
- URI 106-260623
- Acronym
- LeakyBraInCS
- Status last verified
- May 2024
- First submitted
- 3 Jul 2023
- Last updated
- 10 May 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Major Depression and Periodontal Diseases: Analytical Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05950009
- Acronym / sponsor ID
- LeakyBraInCS / URI 106-260623
- Conditions
- Major Depressive Disorder, Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Jul 2023 (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.
Background: There are epidemiological and preclinical studies in vivo that support the biological plausibility of the association between periodontal diseases and major depression (DM), through the hypothesis of a "leaky mouth" by periodontitis as a source of neuroinflammation. Therefore, this association should be studied in depth in carefully designed cross-sectional studies in humans to specifically assess this relationship.
Objectives: Primary: determine if periodontitis can be associated with the development of DM. Secondary: (1) to estimate the prevalence of periodontal diseases (gingivitis and periodontitis) in patients with and without DM; (2) to determine whether oral, periodontal, and fecal (bacterial, viral, and fungal) metagenomic microbiomes, inflammatory mediators, and intestinal barrier integrity are associated with periodontal and mental health variables.
Material and method:
A cross-sectional analytical study with two groups is designed:
- Control group (without DM): subjects without known mental health pathologies will be included, who present a PHQ-9 index of 5 or less. They will be recruited from the control group of a population-based study PsychoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E). They will be matched by age, gender, and socioeconomic status.
- Group of cases (MD patients): subjects with moderate DM will be selected, characterized by HPQ9 index values of 9 or higher. They will be selected among those patients who attend the Mental Health consultations associated with the San Carlos Clinical Hospital.
The study will consist of three visits:
- Visit in Mental Health Consultations: in this visit the subject will be evaluated to determine if he meets the eligibility criteria. You will be informed of the purpose of the study and you will be invited to participate and sign the informed consent. After that, a structured clinical interview for the DSM-IV (SCID) will be conducted and the subject will fill in a series of specific scales on a study-specific electronic device [Beck Depression Inventory (BDI); UCLA Loneliness Scale, Center for Epidemiologic Studies Depression scale [CES-D]; Childhood Trauma Questionnaire short form (CTQ-SF); The World Health Organization Quality of Life questionnaire (WHOQOL); Hamilton scale (HAM-D17); Global Assessment of Functioning (GAF) Scale].
- Dental School Visit: Subject will receive a comprehensive periodontal examination. A subgingival microbiological sample, a saliva sample and a blood sample will also be taken. The patient will be given a specific vial to collect stool samples.
- At the participant's home: the stool samples will be deposited by the participants at home in the specific collection vial.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases _major depression patients | – | Other: No intervention (observational studies)subjects with moderate or severe major depression, without severe suicide ideation, as characterized by the Patient Health Questionnaire (PHQ)-9 index (values of 9 or greater) and by the Structured Clinical Interview for DSM-5 - (SCID) will be selected. |
| Controls | – | Other: No intervention (observational studies)subjects without mental health pathologies identified by SCID, who present an PHQ-9 index of 5 or below will be included as controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in the case group - MD group- will be selected from those patients seen at the Outpatient Clinic of Institute of Psychiatry and Mental Health of Hospital Clínico San Carlos. Subjects in the control group - Non MD group- will be recruited from the control group of a population-based study PsicoBioma TRIAD (C.P. PSQ-19-2 - C.I. 19/474-E) that is currently being performed by the lab of JCL. They will be matched on age, gender, and socio-economic status. In order to confirm that they are in good mental health, they will receive a pre-screen, online questionnaire to screen for symptoms of anxiety and depression (PHQ-9, STAI).
Key inclusion criteria (3 listed)
- Age greater or equal to 18 years.
- For the case group (MD patients), subjects with moderate or severe major depression, without severe suicide ideation, as characterized by the Patient Health Questionnaire (PHQ)-9 index (values of 9 or greater) and by the Structured Clinical Interview for DSM-5 - (SCID) will be selected.
- For the control group, subjects without mental health pathologies identified by SCID, who present an PHQ-9 index of 5 or below will be included as controls.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women.
- Diabetes mellitus.
- Chronic conditions: HIV infection, chronic intake of NSAIDs.
- Comorbidity with other mental disorders: eating disorders, borderline personality disorders, bipolar disorders, schizophrenia and related disorders, and/or any mental serious disease other than major depression.
- Severe suicide ideation.
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 |
|---|---|---|
| No intervention (observational studies)No intervention (observational studies) | Other | Cases _major depression patients, Controls |
Primary outcome
Periodontitis (presence/absence)
Time frame: Baseline
With the clinical and radiological information, the periodontal diagnosis of the patients will be established according to the 2018 classification of periodontal and peri-implant diseases), which involves determining the stage (I to IV), the extent of the stage (localized, generalized or incisor-molar pattern) and the grade (A, B or C).
11 secondary outcomes
Childhood Trauma Questionnaire short form (CTQ-SF)
Time frame: Baseline
UCLA Loneliness Scale (Spanish version)
Time frame: Baseline
The World Health Organization Quality of Life questionnaire (WHOQOL)
Time frame: Baseline
Beck Depression Inventory (BDI)
Time frame: Baseline
Centre for Epidemiologic Studies Depression scale [CES-D]
Time frame: Baseline
Hamilton scale (HAM-D17)
Time frame: Baseline
Global Assessment of Functioning (GAF) Scale.
Time frame: Baseline
Subgingival microbiota
Time frame: Baseline
Plasma levels of inflammatory mediators
Time frame: Baseline
Saliva microbiota
Time frame: Baseline
Gut microbiota (Stool samples)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Periodontitis, run by Universidad Complutense de Madrid at 2 sites in Spain.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Figuero Ruiz, Prof. (0034913942186, elfiguer@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontitis (presence/absence) (time frame: Baseline). 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 10 May 2024.