Cognitive Markers of Response to Treatment in Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functional assessments : Score Sheehan Disability Scale (SDS)
研究概览
简要总结
Patients with depression are frequently treatment resistant. Clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. Many factors are involved in treatment resistance. As no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment.
The aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and Rush classification).
To explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be aged from 40 to 70, with a major depressive episode diagnosis with a 2 stage degree of resistance.
排除标准
- •Patients with major depressive episode during more of 12 months
- •Alzheimer dementia or related disease (CIM 10)
- •Score Hamilton Depression Rating Scale (HDRS) < 18
结局指标
主要结局
Functional assessments : Score Sheehan Disability Scale (SDS)
时间窗: Change from the baseline Score Sheehan Disability Scale (SDS) at 12 months after introducing the new therapy
The investigators will conduct functional assessments. A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; 2 weeks after treatment change, patient will be functional assessed by his psychiatrist. A complete assessment will be done 6 months and 12 months after introducing the new therapy.
Clinic assessments: Score BDI - II
时间窗: Change from the baseline score BDI-II at 12 months after introducing the new therapy
The investigators will conduct clinical assessments. A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; 2 weeks after treatment change, patient will be clinically assessed by his psychiatrist. A complete assessment will be done 6 months and 12 months after introducing the new therapy.
Neuropsychologic assessments: M.M.S.E. (Mini Mental Score Evaluation)
时间窗: Change from the baseline Score M.M.S.E. (Mini Mental Score Evaluation) at 12 months after introducing the new therapy
The investigators will conduct neuropsychologic assessments. A baseline will be drawn in the acute phase (V1) before modifying the antidepressive therapy; A complete assessment will be done 6 months and 12 months after introducing the new therapy.
次要结局
未报告次要终点