An observational study in Major Depressive Disorder and Periodontitis, sponsored by Universidad Complutense de Madrid. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Universidad Complutense de Madrid · Observational
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:
The study will consist of three visits:
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's planned enrollment of 122 is close to the median of 135 across 365 observational studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Universidad Complutense de Madrid is the lead sponsor of 202 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Other: No intervention (observational studies)
No intervention (observational studies)
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).
Time frame: Baseline
Childhood Trauma Questionnaire short form (CTQ-SF)
Range: 25 to 125. A higher score means more (and worst) traumatic experience.
Time frame: Baseline
UCLA Loneliness Scale (Spanish version)
Range: 20 to 80. Higher scores indicatehigher levels of loneliness
Time frame: Baseline
The World Health Organization Quality of Life questionnaire (WHOQOL)
Range: 0 to100. A higher score means better quality of life.
Time frame: Baseline
Beck Depression Inventory (BDI)
Range: 0 to 63. A higher score means more severe-depressive symptomatology
Time frame: Baseline
Centre for Epidemiologic Studies Depression scale [CES-D]
Range: 0 to 60. Higher scores indicate the presence of more severe symptomatology
Time frame: Baseline
Hamilton scale (HAM-D17)
Range: 0 to 52. The higher the score, the more severe the depressive symptoms
Time frame: Baseline
Global Assessment of Functioning (GAF) Scale.
Range: 1 to 100. A higher score means better functioning. A score of 0 means Inadequate information.
Time frame: 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.
Time frame: Baseline
Plasma levels of inflammatory mediators
plasma levels of inflammatory mediators IL-1β, TNF-α, IL-6, prostaglandin E2 and CPRhs
Time frame: 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
Time frame: 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
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Jan 2026, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Complutense de Madrid →