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NCT05257902Completed

Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints

Evaluation of Clinical Effectiveness of Choline Alphoscerate for Older Adults With Major Depression and Subjective Memory Complaints: a Double-blinded, Placebo-controlled, Randomization, Multicenter Investigator-initiated Trial

Source: ClinicalTrials.gov · Last updated 27 Jul 2026

Brief summary (registry, in English)

To evaluate the efficacy of choline alphoscerate on improving symptoms related to depression, anxiety, and subjective memory complaints compared to placebo in patients with Major Depressive Disorder(MDD) accompanied with subjective cognitive decline, who are over the age of 60.

Status (registry)
Completed
Study type
Interventional
Enrollment
120 (actual)
First submitted
17 Jan 2022
Start date
19 Aug 2022
Primary completion date
27 May 2026
Lead sponsor
Samsung Medical Center
Diseases
Depression
NCT number
NCT05257902

What you commit to

  • Study type: Interventional
  • Participants enrolled: 120
  • From 19 Aug 2022 to the primary completion date, 27 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have been taking medication of typical antipsychotics, mood stabilizer, cognitive enhancer including donepezil, rivastigamine, galantamine, and memantine within 1months.
  • Participants who had previous history of liver disease or renal disease

Other illness

  • Diagnosed as schizophrenia, bipolar disorder, PTSD, OCD or other significant mental disorder under the criteria of DSM-5 (only the participants who had depressive disorder, sleep disorder, and the anxiety disorder are allowed to be included)
  • Who have medically unstable disease (only the participants, who have diabetes mellitus or hypertension under control with stable medication for 3 months could be included)
  • Diagnosed as dementia or mild cognitive impairment
  • Participants who had allergic reaction to choline alfoscerate
  • Other specific condition, which could be inappropriate for the trial inclusion, under the judgement of the principal investigator

Other

  • Participants who are already taking choline alfoscerate within 4 weeks of period

Who the study is looking for

  • Age ≥ 60 years
  • Diagnosed as MDD under the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed with MINI-Depression
  • HAM-D ≥ 14
  • MMSE ≥ 20
  • Who had continuous subjective memory complaints more than 6 months before the period of screening
  • Who had taking antidepressants longer than 1 month in the period of screening

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.