Central Glutathione Levels in Women With Late Life Depression: a Cross Sectional Pilot Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of potential participants approached per month.
研究概览
简要总结
Female participants with an episode of late-life depression (LLD) and age-matched control participants with no history of mental disorder will attend a one hour Magnetic Resonance Imaging (MRI). A 3 Tesla MRI scanner will be used to measure levels of glutathione (GSH) in the brain via magnetic resonance spectroscopy (1H MRS).
详细描述
This is a pilot/feasibility, single-centre, open-label, cross-sectional study. Research participants will be women aged 60 to 85. This study seeks to recruit 26 female participants; 13 participants with a confirmed diagnosis of late-life depression and 13 control participants with no history of mental illness. This pilot study will be used to determine if a larger Randomized Controlled Trial is feasible.
The role of antioxidant capacity in Late Life Depression (LLD) has thus far been inadequately assessed, providing the investigators with a timely opportunity to spearhead such an investigation. The results of this pilot study, and subsequent large-scale studies, will allow the investigators to identify novel targets for therapeutic intervention in LLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Late-life depression population inclusion criteria
- •Patients in the LLD study arm will be females 60-85 years of age with a general good bill of health
- •Patients in the LLD study arm will be presenting with mild to moderate MDD. Diagnosis of MDD will be confirmed through a Structured Clinical Interview for DSM-5-TR (SCID) Axis I disorder.
- •LLD patients will have a Hamilton Depression Rating Scale (17-item version) score between 8-22
- •LLD patients if being treated with any antidepressant agent, will be at a minimum of 4 weeks at therapeutic dosage of medication.
- •Healthy control (HC) population inclusion criteria:
- •HC participants will be females between 60-85 years of age and in good general health
- •HC participants will have no history of depression.
排除标准
- •A primary diagnosis of any other mental health disorder (including substance dependence, post traumatic stress disorder, obsessive compulsive disorder, bipolar disorder, neurocognitive disorders, personality disorder, etc.)
- •High risk of suicide as elicited by clinical interview
- •History of head trauma
- •History of severe vascular disease or cerebrovascular infarcts
- •Any history of neurological disease (including Parkinson's disease or seizures)
- •An ongoing acute episode of systemic inflammatory disease (e.g. rheumatoid arthritis, ulcerative colitis, crohn's disease)
- •Any contraindications to MRI
- •Additionally for Healthy Control participants only, a diagnosis of any mental health disorder
结局指标
主要结局
Number of potential participants approached per month.
时间窗: 2 years.
At 2 years the number of potential participants approached per month will be calculated. This information will be used to determine if a larger Randomized Controlled Trial is likely to succeed.
Number of potential participants screened.
时间窗: 2 years.
At 2 years the number of potential participants screened will be assessed. This information will be used to determine if a larger Randomized Controlled Trial is likely to succeed.
Quality of data available for analysis.
时间窗: 2 years
At 2 years the quality of the data available for analysis will be assessed. This information will be used to determine if a larger Randomized Controlled Trial is likely to succeed.
Proportion of screened participants who enroll.
时间窗: 2 years
At 2 years the number of potential participants screened who enroll will be calculated. This information will be used to assess if a larger Randomized Controlled Trial is likely to succeed.
Rate of participant retention
时间窗: 2 years
At 2 years the rate of participant retention will be calculated. This information will be used to assess if a larger Randomized Controlled Trial is likely to succeed.
Cost per participant
时间窗: 2 years
At 2 years the cost per participant will be calculated. This information will be used to assess if a larger Randomized Controlled Trial is likely to succeed.
次要结局
- Central glutathione levels in the brain(week 0)