A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 420
- 主要终点
- rate of PSD within 180 days
研究概览
简要总结
The incidence of depression in stroke patients with frontal lobe involvement was reported to be as high as 42%. Agomelatin, a type 1/2 melatonin receptor agonist and serotonin 2C receptor antagonist, is effective in treatment of depression, but whether it can prevent poststroke depression (PSD) remains unknown. The PRAISED trial is a multicenter, randomized, double-blind trial and is designed to evaluate the efficacy and safety of agomelatine in the prevention of PSD in stroke patients with frontal lobe involvement. The primary outcome is the rate of post-stroke depression for 180 days.
详细描述
This PRAISED trial is a multicenter, randomized, double-blind trial to evaluate the efficacy and safety of agomelatine in the prevention of PSD in patients with acute ischemic stroke. The sample size is 420. The participants will be randomized to receive a 6-month treatment of agomelatine 25mg/d or placebo 25mg/d. The primary end point is the proportion of PSD within 180 days. PSD is defined as the Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by the Diagnostic and Statistical Manual of mental disorders-V (DSM-V). The second end point are rate of recurrence of ischemic stroke within 90 days, modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), vascular death, transient ischemic attack (TIA)/stroke or myocardial infarction during the 6-months, cognitive function(Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), Stroke Specific Quality Of Life (SS-QOL) scale, adherence to medication, adverse events. The study consists of five visits including the day of randomization, day 14±3 days, day 28±3 days, day 90±7 days, day 180±7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18~75 years;
- •within 7 days after stroke onset;
- •CT or MRI showed lesions involving the frontal lobe;
- •mRS≤2 before onset for recurrent ischemic stroke;
- •HAMD-17<8 before enrollment;
- •be consious and able to complete the relevant assessment scales.
排除标准
- •hemorrhagic stroke;
- •with major depressive disorder, or have taken antidepressants within 30 days before stroke onset, or HAMD-17 ≥8;
- •with other mental illnesses;
- •history of drug abuse or alcohol dependence in the past 1 year
- •with life-threatening illnesses or disorders which may affect the completion of the relevant assessment scale (e.g., hearing, language, visual impairment, etc.)
- •with cognitive impairment who cannot complete the relevant assessment scale
- •with serious neurodegeneration diseases (such as Parkinson's disease, Alzheimer's disease, etc.)
- •infection or carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •serum ALT level ≥ 2 times of the upper limit of the reference interval or TBIL level > 1.5 times of the upper limit of the reference interval
- •renal dysfunction (creatinine clearance < 90 ml/min/1.73 m2)
- •allergic to or contra-indicated to agomelatine
- •lactose intolerance
- •pregnant or breast-feeding women
- •withdraw from other clinical trials within 4 weeks or participating in other clinical trials
- •unsuitable for inclusion considered by the investigators
研究组 & 干预措施
Agomelatine
The Agomelatine group will be received agomelatine (25 mg/day) for 180 days.
干预措施: Agomelatine (Drug)
Placebo
The Placebo group will be received placebo (25 mg/day) for 180 days.
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
rate of PSD within 180 days
时间窗: 180 days
PSD is defined as Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by DSM-V.
次要结局
- variation of HAMD-17 score from baseline(14±3 days, 28±3 days, 90±7 days, and 180±7 days)
- variation of Pittsburgh Sleep Quality Index (PSQI) score from baseline(14±3 days, 28±3 days, 90±7 days and 180±7 days)
- rate of recurrence of ischemic stroke within 90 days(90±7 days)
- variation of Epworth Sleepiness Scale (ESS) from baseline(28±3 days, 90±7 days, and 180±7 days)
- variation of National Institutes of Health Stroke Scale (NIHSS) from baseline(28±3 days, 90±7 days and 180±7 days)
- rate of vascular events(180 days)
- rate of sleep disorder(180 days)
- variation of Stroke Specific Quality of Life (SS-QOL) score from baseline(28±3 days, 90±7 days, and 180±7 days)
- rate of all-caused mortality(180 days)
- rate of liver injury(28±3 days, 90±7 days)
- variation of Montreal Cognitive Assessment (MOCA) from baseline(28±3 days, 90±7 days, and 180±7 days)
- variation of Fatigue Severity Scale (FSS) from baseline(28±3 days, 90±7 days, and 180±7 days)
- variation of Modified Rankin Scale (mRS) score from baseline(28±3 days, 90±7 days and 180±7 days)
- variation of Mini Mental State Examination (MMSE) score from baseline(28±3 days, 90±7 days, and 180±7 days)
研究者
Jinsheng Zeng, MD, PhD
Professor
First Affiliated Hospital, Sun Yat-Sen University