A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 主要终点
- The efficacy of the treatment on the sleep disorders in Parkinson's disease evaluated by PSQI scale score change
研究概览
简要总结
Among the patients with Parkinson's disease, about 40%~50% will suffer from depression, 40% will suffer from anxiety, and 40%~60% will suffer from sleep disorder. These non-motor symptoms of Parkinson's disease will cause great physical and psychological pain and affect the quality of life seriously. Commonly used therapeutic drugs, such as selective serotonin reuptake inhibitor (SSRI) and clonazepam, can cause a variety of side effects, including serotonin syndrome, sexual dysfunction, daytime fatigue, insomnia, residual effects and increased risk of falls. Therefore, a new and more reasonable therapeutic choice should be sought. Agomelatine is a new type of antidepressant with novel mechanism, and can improve sleep structure and circadian rhythm. The aim of this multi-center randomized controlled trial (RCT) is to clarify the role of agomelatine in improving sleep disorders and depression in patients with Parkinson's disease
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)
盲法说明
double-blind placebo control
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as Parkinson's disease conforming to 2015 International Movement Disorder Society(MDS) diagnostic criteria
- •Hoehn-Yahr ≤ 3 at "open" stage
- •Mini-mental State Examination(MMSE) ≥ 24 points;
- •Pittsburgh Sleep Quality Index (PSQI) > 7 points;
- •HAMD-17 > 13 points
- •Pramipexole hydrochloride tablets 0.75mg / d (0.25mg tid) has been used stably for one month
- •Signed informed consent
排除标准
- •Parkinson's syndrome and Parkinsonism-Plus syndrome
- •Parkinson's movement symptoms are still fluctuating or the treatment of Parkinson's movement symptoms is unstable
- •Hepatitis B virus carriers/patients, hepatitis C virus carriers/patients, patients with impaired liver function or elevated transaminase levels above the upper limit
- •Other serious neurological diseases, mental illnesses and physical illnesses
- •History of alcohol and drugs dependence
- •Combined treatment with CYP1A2 strong inhibitor (fluvoxamine, ciprofloxacin, rifampicin, amiodarone, mexiletine, atazanavir, etc.)
- •High suicide risk or suicide attempt within 6 months (third item of HAMD-17 ≥ 3)
- •Antidepressant medication or other psychiatric treatment in the past month
- •pregnant or lactating
- •intolerance or allergy to agomelatine active ingredients and excipients
- •other conditions that are not suitable for the study considered by the investigators
研究组 & 干预措施
control group
treated with Pramipexole 0.75mg/d（0.25mg tid)+placebo 25mg qn *2weeks than Pramipexole 0.75mg/d（0.25mg tid)+placebo 50mg qn * 10 weeks
干预措施: Agomelatine or PIacebo (Drug)
experimental group
treated with Pramipexole 0.75mg/d（0.25mg tid)+Agomelatine25 mg qn *2weeks than Pramipexole 0.75mg/d（0.25mg tid)+Agomelatine 50mg qn * 10weeks
干预措施: Agomelatine or PIacebo (Drug)
结局指标
主要结局
The efficacy of the treatment on the sleep disorders in Parkinson's disease evaluated by PSQI scale score change
时间窗: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
The Pittsburgh sleep quality index (PSQI) is a widely used sleep evaluation scale in the Chinese population. The sensitivity and specificity of the PSQI (cut-off at 7) are 98.3% and 90.2%, respectively. PSQI has been used to evaluate the sleep disorders in patients with Parkinson's disease focusing on their sleep habits primarily.
次要结局
- The efficacy on the circadian rhythm of patients with Parkinson's disease(visit1(baseline),visit3(6th week),visit4(12th week))
- Dosage and frequency of sedative and hypnotic drugs(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The efficacy on the movement of patients with Parkinson's disease(visit1(baseline),visit3(6th week),visit4(12th week))
- The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the total number of red blood cells.(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the platelet count.(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the renal function(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- Adverse Event and Serious Adverse Event(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The efficacy of the treatment on the sleep disorders in Parkinson's disease evaluated by PDSS, sleep diary and activity trackers(PDSS:visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week); Sleep diary and activity trackers: 12 weeks, through study completion.)
- The efficacy on the excessive daytime sleepiness of patients with Parkinson's disease(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The efficacy on the fatigue of patients with Parkinson's disease(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The efficacy on the anxiety of patients with Parkinson's disease(visit1(baseline),visit3(6th week),visit4(12th week))
- The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the liver function(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The efficacy on the rapid eye movement sleep behavior disorder (RBD) of patients with Parkinson's disease(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The efficacy on the depression of patients with Parkinson's disease(visit1(baseline),visit3(6th week),visit4(12th week))
- The efficacy on the life quality of patients with Parkinson's disease(visit1(baseline),visit3(6th week),visit4(12th week))
- The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the total number of white blood cells.(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
- The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the concentration of the hemoglobin.(visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week))
研究者
Chun-Feng Liu
Professor
Second Affiliated Hospital of Soochow University