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

NCT05257902 | Unknown

• 1 other identifier: 2021-10-033
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Major Depression

Keywords

subjective memory complaints

Outcome Measures

Primary Outcomes (1)

• Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression

  Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression between the baseline and visit 5, higher scores mean a worse outcome

  between baseline and 8weeks

Secondary Outcomes (8)

• The difference between baseline and each period of visit in the score of the first questionnaire of Memory Functioning Questionnaire (MFQ)

  between baseline and each 2weeks, 4weeks, 6weeks, 8weeks

• The difference between baseline and each period of visit in the score of the total Geriatric Depression Scale (GDS)

  between baseline and each 2weeks, 4weeks, 6weeks, 8weeks

• The difference between baseline and each period of visit in the score of the Mini-Mental State Examination(MMSE)

  between baseline and each 2weeks, 4weeks, 6weeks, 8weeks

• The difference between baseline and each period of visit in the score of the Hamilton Rating Scale for Depression(HAM-D)

  between baseline and each 2weeks, 4weeks, 6weeks, 8weeks

• The difference between baseline and each period of visit in the score of the Hamilton Rating Scale for Anxiety (HAM-A)

  between baseline and each 2weeks, 4weeks, 6weeks, 8weeks

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants.

Drug: choline alphoscerate

Control Group

PLACEBO COMPARATOR

Participants in the control group will take the placebo, which would not affect their medical condition, for the adjunctive therapy is the choice of agreement between clinician and participants. If there is the necessity of change in antidepressant or of adjustment of their dosage, investigator can stop the clinical trial and proceed to another treatment.

Drug: Placebo

Interventions

choline alphoscerate DRUG

400mg bid/day

Treatment group

Placebo DRUG

Placebo 1T bid/day

Control Group

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 are already taking choline alfoscerate within 6 months of period
• Participants who have been taking medication of antipsychotics (including quetiapine), mood stabilizer, cognitive enhancer including donepezil, rivastigamine, galantamine, and memantine within 1months.
• Participants who had previous history of liver disease or renal disease
• Participants who had allergic reaction to choline alfoscerate

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Glycerylphosphorylcholine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glycerophosphates; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Glycerophospholipids; Phosphatidic Acids; Phospholipids; Membrane Lipids; Lipids; Lecithins; Phosphatidylcholines

Study Officials

• Hong Jin JEON

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jin JEON

CONTACT

82-2-3410-3586; jhj.jeon@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 25, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 25, 2022

Record last verified: 2022-02