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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression
研究概览
简要总结
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.
详细描述
This clinical trial will include the participants over age 60, diagnosed as MDD under treatment of antidepressant longer than 1 month's period, assessed as Hamilton Rating Scale for Depression(HAM-D) ≥ 14, and Mini-Mental State Examination(MMSE) ≥ 20, and those who are accompanied with subjective memory complaints. The investigators will evaluate the clinical efficacy of symptomatic improvement in depression, anxiety, and subjective memory complaints. The investigators will assess these outcomes including memory function, depression, anxiety, and satisfaction on medication with scales comparing control group with treatment group under 8 weeks of medication.
This is a multi-center, randomized, double-blind, placebo-controlled, Phase IV trial to evaluate the efficacy.
Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Diagnosed as MDD under the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and confirmed with MINI-Depression
- •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
排除标准
- •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 4 weeks of period
- •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
- •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
研究组 & 干预措施
Control Group
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.
干预措施: Placebo (Drug)
Treatment group
Participants in the treatment group will take the choline alfoscerate as adjunctive therapy with their own antidepressants.
干预措施: choline alphoscerate (Drug)
结局指标
主要结局
Change of the total score of Korean version of Perceived Deficits Questionnaire-Depression
时间窗: between baseline and 8weeks
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
次要结局
- The difference the score(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)
- The difference between baseline and each period of visit in the score of the total score of Medication Satisfaction Questionnaire (MSQ)(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 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)
- assessement AE(between baseline and each 2weeks, 4weeks, 6weeks, 8weeks)
研究者
hong jin jeon
Principal Investigator
Samsung Medical Center