Predictors of Treatment Response in Late-onset Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 主要终点
- Resting Functional brain MRI
研究概览
简要总结
Depression is a common disorder, especially in old age, where it is associated with significant morbidity and mortality.
This study will investigate whether there are features of individual patients with major depression that may predict positive treatment response. The study will invite 40 patients who have been diagnosed with major depressive disorder with onset after the age of 60 years to participate. Participants will be recruited from the Mental Health of Older Adults services at the South London and Maudsley NHS Mental Health Foundation Trust. Participants will receive usual treatment as set out in standard Care Pathways, used by the clinical care team. As part of the study, they will undergo a short battery of neuropsychological tests and a standard MRI brain imaging protocol. The neuropsychological tests and assessment of depression severity will be carried out twice (at Baseline and Week 12). Data will be analysed to investigate whether there are features specific to those patients who show a good response to antidepressant treatment after 12 weeks. Identification of such predictors may help to stratify treatment approaches in the future and lead to the early identification of individual patients who may require alternative treatment approaches to standard antidepressants.
详细描述
Aim and objectives:
Predictors of treatment response may help to improve treatment approaches in late-onset major depression patients. The study will identify features of patients with major depression that may predict good and poor treatment response. It will use demographic, clinical, neuropsychological and brain MRI data to investigate the potential value of these as predictors of response to standard treatment over 12 weeks. For example, impairment of executive functioning on cognitive testing may predict patients whose depression does not respond to 12 weeks of treatment. MRI may reveal specific characteristics that predict good response to treatment.
Methodology Subject inclusion and exclusion criteria Inclusion: Patients with major depressive disorder, diagnosed for the first time after the age of 60 years, with a Mini Mental State Examination score >24/30.
Exclusion: Participants with a history of other major psychiatric illness or intellectual disability will be excluded. Those who have unstable medical conditions, including a history of neurological disease (stroke, epilepsy, recent delirium, neurodegenerative disease or dementia) will also be excluded.
Recruitment:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is 60 or more years old at the point of first contact with psychiatric specialist services for depression.
- •Satisfies diagnostic criteria for current major depressive disorder according to DSM-IV TR (American Psychiatric Association, 2000)
- •Mini-Mental State Examination (MMSE) score of 25 or greater.
排除标准
- •Previously diagnosed with other major psychiatric illness (schizophrenia, bipolar disorder, benzodiazepine/ substance dependence or personality disorder) or registered intellectual disability.
- •Severe or unstable medical condition e.g. severe infection, myocardial infarction, renal failure or metastatic cancer. Including those who have stroke, epilepsy, delirium within 3 months, neurodegenerative disease or dementia.
- •History of traumatic brain injury with more than 10 minutes of loss of conscious period.
- •Metal implants that would be a contraindication for MRI.
研究组 & 干预措施
Treatment responder
Participants who receive standard care and achieve HAM-D score reduction of 50% or more, or score below 8 at Week 12.
干预措施: Standard care (Drug)
Treatment non-responder
Participants who receive standard care but have HAM-D score reduction less than 50% at Week 12.
干预措施: Standard care (Drug)
结局指标
主要结局
Resting Functional brain MRI
时间窗: Week 4 after enrollment
resting stage functional MRI of brain, eyes closed
次要结局
- Neuropsychological test battery(at entry and endpoint (Week12))
- Structural brain MRI(Week 4 after enrollment)
- Functional assessment(at entry and endpoint (Week12))