Choline Alfoscerate in the Treatment of Subthreshold Depression in the Elderly: A Pilot Study (CARTESIO)

Background: Subthreshold depression is a prevalent condition among the elderly and often remains untreated due to limited efficacy and poor tolerability of standard antidepressants. Choline alfoscerate, a cholinergic precursor, is indicated for the treatment of a condition, pseudodepression in the elderly, that is currently clinically classified as subthreshold depression in older adults. Also, choline alphoscerate has shown neuroprotective and antidepressant-like effects. Objective: This pilot study aims to evaluate the efficacy and safety of choline alfoscerate in elderly patients with subthreshold depressive symptoms, using the most recent diagnostic assessments of the clinical condition and the treatment outcomes. Methods: Seventeen patients aged ≥65 years were enrolled in an open-label, single-arm study and received 1,200 mg/day of choline alfoscerate for 8 weeks. Clinical and neuropsychological assessments were performed at baseline, after 4 weeks and at study end. Results: A statistically significant improvement was observed in depressive symptoms as reflected by reductions in HAMD-17 (p < 0.001) and GDS-15 scores (p < 0.05), as well as in overall clinical severity assessed by the Clinical Global Impression–Severity scale (CGI-S, p < 0.05). No significant changes were noted in cognitive performance (MOCA) or apathy (AES-I). The treatment was well tolerated. Conclusion: Choline alfoscerate represents an effective and safe option for subthreshold depression in older adults. Further controlled and long-term studies are warranted to confirm its efficacy not only on depressive symptoms but also on cognitive function and other relevant clinical outcomes, such as global functioning in elderly patients with subthreshold depression.