Treatment Resistant Geriatric Depression in Primary Care: Is NAAG (N-Acetylaspartylglutamate), Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS) at 3 Tesla, a Predictor of Treatment Response?
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean Differences in NAAG Levels between Subject Groups at Baseline and Week 8
研究概览
简要总结
This study involves collaboration between McLean Hospital, Geriatric Medicine at the Cambridge Health Alliance (CHA) and other sites within the Partners and Harvard Medical School network. The investigators plan to recruit individuals 55 to 89 years old with treatment resistant depression. Someone with "treatment resistant" depression for this study may be someone who still has sad or low feelings and thoughts even though he/she is taking an antidepressant medication for at least 8 weeks to help relieve his/her depression. During the study, subjects will gradually add memantine hydrochloride in dosages up to 20 mg/day for 8 weeks to their standard antidepressant treatment.
The investigators are doing this research study to help answer 3 questions:
- Do older adults with treatment resistant Major Depression have lower levels of a chemical in the brain called NAAG than older adults without Major Depression?
- Do older adults with naturally low NAAG levels do better on memantine hydrochloride treatment than older adults with higher amounts of this chemical on memantine hydrochloride treatment?
- Do older adults with treatment resistant depression have more problems with memory and concentration than older adults without depression?
The investigators are also interested in looking at electrical and neuronal activity of the brain, spiritual beliefs, and fatigue in relationship to depression.
The investigators hypothesize that:
- Older individuals with treatment resistant Major Depression will have lower levels of NAAG compared with age-matched older control subjects.
- Older adults with treatment resistant depression and low NAAG levels will do better on treatment with memantine hydrochloride than older adults on memantine with higher NAAG levels.
- Older adults with depression will do better on tests of attention and executive functioning after treatment with memantine hydrochloride.
- Healthy controls will do better on tests of attention and executive functioning than older adults with depression.
详细描述
RESEARCH DESIGN AND METHODS
We will enroll up to 20 subjects with major depression, ages 55-89, and up to 20 healthy control subjects, ages 55-89 matched with depression group for age, sex, and ethnicity. We require 10 subjects in each group to have completed the study protocol with clinical and MRI scan data suitable for analysis.
Subjects in both groups will be recruited from:
- Cambridge Health Alliance (CHA) geriatric medicine group practice.
- Mount Auburn Outpatient programs and affiliates
- Beth Israel Deaconess Medical Center Outpatient programs and affiliates
- McLean Hospital Geriatric Psychiatry Outpatient, Inpatient, and Partial (SAGE - Seniors Aging Gracefully Everyday) programs
- Other inpatient, partial, and outpatient psychiatry programs at McLean Hospital
- Outpatient programs affiliated with Partners Healthcare and/or Harvard Medical School, such as:
- Partners Community Health Care primary care physicians (PCPs),
- Massachusetts General Hospital and Brigham and Women's PCP network
- Local geriatricians and community psychiatrists
- General public and community (through IRB-approved local advertisements), such as:
- Public areas (gyms, super markets, etc)
- Retirement communities
- The Harvard Division on Aging
- Newspaper
- Radio
- Internet
- McLean Hospital Geriatric Psychiatry Research Program's research studies, including:
- Subjects who have completed participation in treatment or non-treatment studies
- Subjects who are actively participating in non-treatment research studies
One site (McLean Hospital) is engaged in this protocol. CHA and other sites only refer subjects to McLean and do not consent subjects or complete any study protocol procedures. Subjects must meet all selection criteria in order to participate in the study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Memantine hydrochloride
Older individuals with DSM IV TR Major Depression, with persistent symptoms of depression despite at least 8 weeks of treatment with standard pharmacotherapy, will be referred for a study of memantine hydrochloride augmentation. Healthy control subjects follow similar study schedule for baseline and endpoint but do not receive memantine hydrochloride.
干预措施: Memantine (Drug)
结局指标
主要结局
Mean Differences in NAAG Levels between Subject Groups at Baseline and Week 8
时间窗: Baseline / Study Entry
Are NAAG levels are lower in older adults with treatment resistant depression compared with healthy age-matched controls?
次要结局
- Relationship of NAAG Levels and MADRS Scores between Subject Groups at Baseline and Week 8(8-week trial)
- Cognitive Impairment between Subject Groups at Baseline and Week 8(8-week trial)
研究者
Brent Forester
Geriatric Psychiatrist / Principal Investigator
Mclean Hospital