A Double-blind Randomized Controlled Trial of Adenosine Disodium Triphosphate in Improving Moderate to Severe Depressions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HAMD-24
研究概览
简要总结
This clinical study is a randomized, double-blind, placebo-controlled trial with an intervention period of 4 weeks. Participants will be patients with moderate to severe depression who meet the inclusion criteria during the screening period. After recruitment written informed consent form will be signed and the baseline evaluation will be done then the treatment period follows. The subjects will be randomly assigned to a control group (escitalopram plus normal saline(NA)) and an ATP group (escitalopram plus adenosine disodium triphosphate(ATP)) in a 1:1 ratio for treatment, with a total number of 120 recruited patients. Assessment will be carried out as an analysis of changes in Hamilton Depression Scale（HAMD-24）, cognitive function test, brain functional network, inflammatory markers, and other indicators in the first, second, and fourth week of intervention which will evaluate the effectiveness of ATP in improving moderate to severe depression preliminarily.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic and statistical manual of mental disorders-5 diagnostic criteria for moderate to severe depression.
- •HAMD-24 scores ≥
- •18-65 female or male.
- •Participants who have not used any psychotropic medications within one month prior to study and never had a treatment with escitalopram.
- •Individuals without contraindications to selective serotonin reuptake inhibitor.
- •Individuals without contraindications to ATP.
- •Written informed consent.
排除标准
- •Participants with various major mental disorders other than depression (bipolar disorder, any psychotic disorder, Personality Disorders, alcohol use disorder, substance use disorder, and disorders due to medical or organic cause) assessed using Chinese version of the Mini International Neuropsychiatric Interview (MINI).
- •Individuals with neurological disorders such as dementia.
- •Individuals with a high risk of suicide.
- •Pregnant and lactating women.
- •Contraindications to MRI.
- •Physician evaluation was not suitable for participants in this study.
研究组 & 干预措施
Placebo Group
Cap escitalopram 10mg once daily (OD) for four weeks and injection 110ml NS twice daily (BD) for two weeks.
干预措施: Placebo Group (Drug)
ATP Group
Cap escitalopram 10mg OD for four weeks and injection ATP 100mg in 100ml NS BD for two weeks.
干预措施: ATP Group (Drug)
结局指标
主要结局
HAMD-24
时间窗: Baseline, two weeks, and four weeks
Changes in HAMD-24. Score range from 0-76, higher scores mean a worse outcome.
次要结局
- Monetary Incentive Delay Task(Baseline, two weeks, and four weeks)
- Snaith-Hamilton Pleasure Scale(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Insomnia Severity Index(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Diffusion Tensor Imaging(Baseline, two weeks, and four weeks)
- Emotional faces processing task(Baseline, two weeks, and four weeks)
- Clinical Global Impression(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Columbia-Suicide Severity Rating Scale(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Attention network test(Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Diffusion Spectral Imaging(Baseline, two weeks, and four weeks)
- Quantitative susceptibility mapping(Baseline, two weeks, and four weeks)
- Resting state functional connectivity(Baseline, two weeks, and four weeks)
- Hamilton Anxiety Scale(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Antidepressants Side Effects(One week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- C-reactive protein(Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Interleukin- 6(Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks)
- N-back task(Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Beck Depression Inventory(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Tumor Necrosis Factor α(Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Psychomotor vigilance task(Baseline, two weeks, four weeks, twelve weeks, twenty-four weeks)
- Hamilton Depression Scale(Baseline, one week, twelve weeks, twenty-four weeks)
- Montgomery and asberg Depression Rating Scale(Baseline, one week, two weeks, four weeks, twelve weeks, twenty-four weeks)