An interventional study of L-serine supplementation and Placebo in Late-Life Depression, sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli. Recruiting at 1 site in Italy. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Not applicable, Interventional, and Supportive care
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Among 101 studies in Depression with a site in Italy — 31 open to participants now, 32 under way, 2 of them phase 3. Depression · Italy.
Among the 101 studies in Depression with a site in Italy, this one is the 45th largest by planned enrollment of the 74 interventional ones that give a count, is one of 2 that started in 2026, is one of 47 with no phase, reaches primary completion later than 26 of the 31 other live ones, and was the 99th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →31 of the 101 studies in Depression with a site in Italy are open now. Recruiting first, the newest first:
IRCCS Centro Neurolesi Bonino Pulejo · Sites in Italy
Ages 18–60
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
Ages 18+
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+
IRCCS Centro San Giovanni di Dio Fatebenefratelli · Sites in Italy
Ages 50–80
IRCCS Policlinico S. Donato · Sites in Italy
Ages 18+ · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
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101 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 84 is close to the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 102 across the 74 interventional studies, 200 across the 27 observational. Of the 50 that completed or were terminated, 10 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
18 of 101 have an industry lead sponsor. The 10 most frequent:
IRCCS Centro San Giovanni di Dio Fatebenefratelli is the lead sponsor of 36 studies on the registry; 15 are open to participants now.
IRCCS Centro San Giovanni di Dio Fatebenefratelli has 5 studies filed under Depression — fewer than ten, so there is no comparison to draw.
3 of the studies in Depression with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589544University Hospital of FerraraNon-pharmacological Care for Depression in Cancer Patients Using VR and TMS | 2026-12-31 |
| NCT06724029Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaNeurosurgical Outcome Network | 2027-06 |
| NCT06395558Azienda Usl di BolognaintErnet-based iNterventions FOR Cardiac arrEst suRvivors | 2027-08-05 |
Add all 3 to your calendar (.ics) → With an account.
Among the 101 studies in Depression with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this clinical trial is to investigate the effects of L-serine supplementation on cognitive decline and psychosocial functioning in older adults with late-life depression (LLD). The study will evaluate changes in depressive symptoms, neural and cognitive functioning, and will assess neurophysiological, metagenomic, and biochemical alterations associated with L-serine supplementation compared with placebo.
The main research questions are:
All participants will be assessed at three time points: T0 (baseline, prior to trial initiation), T18 (after 18 weeks), and T48 (after 48 weeks, at the end of the trial).
At each assessment, participants will:
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:
L-serine supplementation, 6 g/day, oral stick, 48 weeks.
Dietary Supplement: L-serine supplementation
Maltodextrine supplementation, 6 g/day, oral stick, 48 weeks.
Other: Placebo
Participants randomized to the experimental arm will receive L-serine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks.
Participants randomized to the Placebo arm will receive Maltodextrine supplementation (6 g/day), administered orally as a single stick per day for a total duration of 48 weeks.
Geriatric Depression Scale - 15
The Geriatric Depression Scale - 15 items (GDS-15) is a validated clinical instrument widely used in clinical and research settings to screen for depressive symptoms in older adults.
Time frame: Baseline; week 18; week 48 (end of the trial)
Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological (RBANS) is a neuropsychological battery composed of 12 subtests grouped into five domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. It yields index scores and a total scale score. Higher scores indicate better cognitive functioning, reflecting a more favorable clinical outcome.
Time frame: Baseline, Week 18; Week 48 (end of the trial)
Patient Health Questionnaire - 9
The Patient Health Questionnaire-9 (PHQ-9) is a self-administered instrument used to assess the severity of depressive symptoms based on DSM criteria. It consists of 9 items, each rated from 0 (not at all) to 3 (nearly every day), resulting in a total score ranging from 0 to 27. Higher scores reflect more severe depressive symptoms, indicating a worse clinical outcome.
Time frame: Baseline; Week 18; Week 48 (end of the trial)
Montgomery-Åsberg Depression Rating Scale
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
Time frame: Baseline, Week 18; Week 48 (end of the trial)
World Health Organization Quality of Life - Bref
The World Health Organization Quality of Life - Bref (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.
Time frame: Baseline, Week 18, Week 48 (end of trial)
Electroencephalogram -derived neurophysiological metrics
Electroencephalogram (EEG) recordings will be used to derive individual spectral analysis and connectivity.
Time frame: Baseline, Week 48 (end of the trial)
Gut Microbiome Composition
Assessment of gut microbiome composition through analysis of fecal samples using high-throughput sequencing techniques (e.g., 16S rRNA gene sequencing). Microbial diversity (alpha and beta diversity) and relative abundance of bacterial taxa will be evaluated.
Time frame: Baseline, Week 18; Week 48 (end of trial)
Immune-related biomarkers levels
Plasma and serum levels of immune-related biomarkers will be measured, including cytokines and chemokines, C-reactive protein (CRP), and NLRP3. Quantitative assessment will be performed using validated laboratory assays. Changes in biomarker concentrations over time will be evaluated.
Time frame: Baseline; Week 18; Week 48 (end of trial)
Amino acid and metabolic biomarkers
L-serine and D-serine concentrations will be measured in blood, urine, and fecal samples using validated analytical methods. Quantitative assessment of biomarker levels and changes over time will be performed.
Time frame: Baseline, Week 18; Week 48 (end of trial)
Neuroendocrine and stress-related biomarkers
Cortisol levels will be measured in blood samples and corticosterone levels in fecal samples using validated analytical methods. Quantitative assessment of biomarker concentrations and changes over time will be performed.
Time frame: Baseline, Week 18; Week 48
Neurotrophic biomarkers
Changes in brain-derived neurotrophic factor (BDNF) levels will be measured in blood samples
Time frame: Baseline, Week 18; Week 48
Started Mar 2026 (actual). Primary completion is estimated for Jun 2028, 27 months after the start.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 27 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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IRCCS Centro San Giovanni di Dio Fatebenefratelli