Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Anxiety score
研究概览
简要总结
This study is a single-center, parallel and double-blind study in Movement Disorders Clinic of Shohadaye Tajrish Hospital. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. After assessing the inclusion and exclusion criteria's, patients who assigned the informed consent form, are randomly divided into control and treatment groups.Patients in treatment or placebo groups respectively receive mirtazapine (15 mg) or placebo, once a day for 12 weeks. Primary (anxiety) and secondary (depression, fatigue, sleep disorders, and quality of life) outcomes are evaluated at baseline, and after 4 and 12 weeks of treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 17 years old
- •Patient with Parkinson's disease according to UKPDSBB criteria
- •Patient with mild/moderate Parkinson's disease according to Hoehn and Yahr Scale (HY score = 1-3)
- •Self-report or clinical diagnosis of anxiety
- •Patients who have signed informed consent to participate in the study.
排除标准
- •Pregnant and lactating women
- •Parkinson's patients with onset of disease in less than 1 year
- •Unstable medication for Parkinson's disease during the last two weeks
- •Parkinson's patients with DBS
- •Patients with other neurodegenerative diseases like multiple system atrophy (MSA), Huntington's and etc.
- •Patients with major depressive disorder
- •A history of using SSRIs, SNRIs, benzodiazepines and β-blockers during the last 4 weeks
- •A history of using MAO inhibitors
- •A history of alcohol and substance abuse
- •A history of acute stress during the last 3 months
- •A history of suicide
- •A history of cardiovascular diseases
- •A history of liver and or kidney disorders
研究组 & 干预措施
Mirtazapine
Mirtazapine (15 mg), once a day, for 12 weeks
干预措施: Mirtazapine 15 MG (Drug)
Placebo
Placebo, once a day, for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Anxiety score
时间窗: Baseline, and after 4 and 12 weeks of treatment
Parkinson Anxiety Scale (PAS) questionnaires
次要结局
- Depression score(Baseline, and after 4 and 12 weeks of treatment)
- Fatigue score(Baseline, and after 4 and 12 weeks of treatment)
- Sleep disorder score(Baseline, and after 4 and 12 weeks of treatment)
- Quality of life score(Baseline, and after 4 and 12 weeks of treatment)
研究者
Leila Dargahi. PharmD PhD
Professor
Shahid Beheshti University of Medical Sciences