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
- 1
- 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
研究组 & 干预措施
Late Life Depressed Arm
Participants in the Late Life Depressed arm will have a confirmed diagnosis of late-life depression.
干预措施: A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain. (Other)
Healthy Control Arm
Participants in the Healthy Control Arm will have no history of mental illness.
干预措施: A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain. (Other)
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)