The Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Difference between two arms in change of Short Form-36 (SF-36) scores
研究概览
简要总结
The study will examine 30 patients between ages 50-80, newly diagnosed with early-stage Parkinson's Disease. Patients will be randomized to receive either Citalopram or Carbidopa-levodopa. The investigators' primary outcome measure will be change in quality of life over a prospective period of 6 months. Secondary outcome measures will include change in mood state and motor symptoms, as well as comparison of improvement between two treatments.
Primary investigators would also like to collect quantitative electroencephalogram (qEEG) recordings, which is a reading of brain activity as an additional interest of this study. Primary investigators will assess the qEEG recordings for electrophysiological findings before and after interventions.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50-80 years of age presenting with diagnoses of early stage Parkinson's Disease (UPDRS part III score <20) without a previous treatment trial of either antidepressants or levodopa and able to provide consent.
- •Screened positive with depressive symptoms suggestive of an underlying mild to moderate major depressive episode on the PHQ-9 (scores 10-20).
排除标准
- •Currently taking an antidepressant (SSRI, SNRI, TCA, MAOi), antipsychotic, or dopaminergic Parkinson medication, or in the last 8 months.
- •Tremor with a UPDRS-part III score of 3 or more.
- •Currently participating in another clinical trial, which might directly influence findings of this study.
- •Inability to provide informed consent.
- •Dementia as defined by Montreal Cognitive Assessment (MoCA) score of <24 and/or clinical evidence of dementia.
- •A lifetime diagnosis of another mental disorder including bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, moderate and severe alcohol use disorder as per chart review or patient self-report.
- •High risk of suicide (e.g. active suicidal ideation and/or current/recent intent or plan) as per self-report or relevant item on the PHQ-
- •Non-correctable clinically significant sensory impairment.
- •Unstable medical illnesses including delirium, uncontrolled diabetes mellitus, hypertension, and hyperlipidemia or cerebrovascular or cardiovascular risk factors that are not under medical management, including QTc>480 on Electrocardiogram.
研究组 & 干预措施
Carbidopa-Levodopa
Patients will be randomized to any of the 2 arms. In Levodopa/carbidopa arm, patients will be taking Carbidopa-Levodopa (25-100mg) three times a day for the duration of the study.
干预措施: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet (Drug)
Citalopram
Patients will be randomized to any of the 2 arms. In Citalopram arm, patients will be taking Citalopram (20mg) daily for the duration of the study.
干预措施: Citalopram (Drug)
结局指标
主要结局
Difference between two arms in change of Short Form-36 (SF-36) scores
时间窗: 6 months
Using a 6-month Randomized Controlled Trial (RCT) intervention study, assess whether Citalopram can improve Quality Of Life (QOL) significantly more than carbidopa-levodopa in early stage Parkinson's disease. This will be measured as a change in SF-36 scores, where the lower scores are associated with more disability. Scores range from 0-100.
次要结局
- Change in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination within Citalopram group(6 months)
- Difference between two arms in change of Unified Parkinson's Desease Rating Scale (UPDRS) part III motor examination(6 months)
- Difference between two arms in change of Patient Health Questionnaire -9 (PHQ-9) score(6 months)
研究者
Mandar Jog
Principal Investigator
London Health Sciences Centre