A Survey of Quality of Life in Chinese Working and School Age Population With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Quality of Life, short form 6 (QOL-6)
研究概览
简要总结
Major depressive disorder (MDD) is a common mental illness with high prevalence and global burden. Previous studies revealed that over 70% patients in remission still had decreased quality of life, severe function impairment, low positive mental health score and poor coping ability. However, few studies focus on working and school age patients with MDD. A GBD survey showed that over 40% MDD patients are 15-50 years old. Therefore, we initiate the present multi-center cross-sectional survey to investigate the associations between clinical symptoms, cognitive function, occupational/study ability, and quality of life in Chinese working and school age population with MDD who are in remission.
详细描述
This is a multi-center cross-sectional study. Patients with MDD who received medication treatment and achieved remission for at least 8 weeks will be enrolled. For all the participants, demographic information will be collected; clinical symptoms, cognitive function, occupational/study ability, and quality of life will be evaluated by using 17-items HAMD, PHQ-9, HAMA, PSQI, SHAPS, HCL-32, SDS, LEAPS, QOL-6, PFQ and THINC-it toolkit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-patients;
- •Men or women aged between 16 and 50, with junior high school education or above;
- •According to medical history, patients should be diagnosed with major depressive episode by two or above psychiatric doctors based on ICD-10 criteria;
- •According to assessment, patients should meet the DSM-5 criteria for MDD when in past episodes;
- •Patients received stable ant-depression medication treatment for at least 8 weeks before enrolment;
- •17-item HAMD total score ≤ 7;
- •Willing to participate in this study, and sign an informed consent.
排除标准
- •HCL-32 total score < 12;
- •Diagnosed with bipolar disorder;
- •Suffering from some serious physical diseases (e.g. moderate or severe brain injury, central nervous system diseases, or other unstable physical condition affecting the whole body) adversely affects the performance on neuropsychological test or rating scales;
- •Received ECT in the past 6 months.
结局指标
主要结局
Quality of Life, short form 6 (QOL-6)
时间窗: up to 4 weeks
To evaluate the quality of life in patients with MDD. The higher the total score, the better the quality of life.
The Psychosocial Function Questionnaire in Patients with Depression (PFQ)
时间窗: up to 1 weeks
To evaluate the psychosocial function of patients with MDD. The lower total score means the severer psychosocial function impairment.
The Sheehan disability scale (SDS)
时间窗: up to 1 weeks
To evaluate the functional impairment, including work/study, daily life and family responsibility. The score of each subscale ranged from 0 to 10 which means from no impairment to loss of function.
次要结局
- The Lam Employment Absence and Productivity Scale (LEAPS)(up to 2 weeks)
- The Hamilton Depression Scale-17 items (HAMD)(up to 1 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(up to 2 weeks)
- The Hamilton Anxiety Scale (HAMA)(up to 1 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(up to 4 weeks)
- The Snaith-Hamilton Pleasure Scale (SHAPS)(up to 4 weeks)
- THINC-it toolkit(up to 1 weeks)