Prospective Clinical Cohort Study of Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Dysfunctional Attitude Scale，DAS
研究概览
简要总结
This is a prospective clinical cohort study of depression. The study was intended to include 300 patients with depression and 100 healthy controls. The study consisted of two phases: the baseline period and the follow-up period, in which all subjects were comprehensively collected, and the follow-up period in which all subjects were followed up at least once a year and data were collected. For patients with major depressive disorder, the follow-up methods included fixed visit and planned visit, and the follow-up time point covered the whole course of depressive disease(baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days). Based on standardized, multi-strategy follow-up system and mobile health technology, long-term follow-up of patients with major depressive disorder was realized, and key nodes of patients' disease fluctuations were captured in time. High quality multidimensional data were collected, including demographic, clinical, EEG and eye movement data. Finally, the objective index system of depression was constructed, and the diagnosis, efficacy/recurrence prediction and suicide warning models of depression were established.
详细描述
- Research Treatment
1.1 Drug treatment
The patient did not take antidepressant treatment at least 14 days before enrollment (the patients treated with fluoxetine before enrollment should stop using it for at least 28 days). During 8 weeks, all subjects with major depressive disorder received effective dosages of selective serotonin reuptake inhibitors, and all subjects with major depressive disorder were limited to a single class of antidepressants. If the antidepressant treatment plan needed to be adjusted, one antidepressant should be selected as far as possible, and combined treatment with two or more antidepressants should not be allowed. Antipsychotics and mood stabilizers are not permitted. If the treatment of selective serotonin reuptake inhibitors is not effective after eight weeks, the drugs can be considered for replacement. The drugs for replacement include but are not limited to selective serotonin reuptake inhibitors.
1.2 Other treatment Settings
Psychotherapy and TMS are allowed. The method, frequency, and duration of therapy should be recorded.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Out-patient or in-patient aged 18-65 years (including 18 and 65 years), regardless of gender;
- •The Chinese version of the Concise International Neuropsychiatric Interview (M.I.N.I.) 7.0.2 type interview, in line with the DSM-5 Diagnostic criteria for major depressive disorder, either first or recurrent;
- •Screening and baseline Hamilton Depression Scale (HAMD-17) Score ≥14;
- •No antidepressants were taken for at least 14 days prior to enrollment (patients treated with fluoxetine prior to enrollment should Stop for at least 28 days);
- •A single class of antidepressant medication is planned;
- •Primary school education or above, able to understand the research content;
- •Understand and voluntarily participate in this study, and I sign the informed consent.
排除标准
- •A current or previous DSM-5 diagnosis of a major mental disorder other than major depressive disorder, Such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, bipolar disorder Sensory disorder, obsessive disorder, panic disorder, post-traumatic stress disorder, alcohol (or drug) dependence or abuse User and personality disorder;
- •depression secondary to an organic mental disorder caused by a systemic disease or a neurological disease Seizures, such as depression caused by hypothyroidism;
- •Severe or unstable cardiovascular, respiratory, liver, kidney, endocrine, hematological or other conditions Other systemic diseases were not considered suitable for inclusion in this study.
- •During the screening period or baseline period, the investigators considered that the physical examination and laboratory examination of the patients were abnormal and judged to have significant clinical significance Bedsense;
- •had received systemic Modified Electric therapy (Modified Electric) 3 months before screening Convulsive Therapy, MECT) or Transcranial Magnetic stimulation (Transcranial Magnetic Stimulation (TMS), Deep Brain Stimulation (DBS), Vagus Nerve Stimulation (VNS);
- •The withdrawal of psychotropic drugs did not reach 7 half-lives before screening.
研究组 & 干预措施
Patients with major depressive disorder
We collect data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days).
干预措施: selective serotonin reuptake inhibitors (Drug)
Patients with major depressive disorder
We collect data of patients with major depressive disorder at different point (baseline, 2nd weekend±7days, 6th weekend±14days, 8th weekend±14days, 12th weekend±14days, Week 14-104 Every 4 weekends ± 14 days).
干预措施: TMS (Device)
结局指标
主要结局
Dysfunctional Attitude Scale，DAS
时间窗: baseline
rating scale
score of Sheehan Disability Scale，SDS
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Snaith-Hamilton Pleasure Scale, SHAPS
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
Generalized Anxiety Disorder,GAD-7
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
Patient Health Questionnare, PHQ-9
时间窗: 6th weekend±14days,
rating scale
Childhood Trauma Questionnaire，CTQ
时间窗: baseline
rating scale
Scale for Suicide Ideation，SSI
时间窗: 6th weekend±14days,
rating scale
Hamilton Anxiety Scale，HAMA
时间窗: 6th weekend±14days,
rating scale
Brief Psychiatric Rating Scale, BPRS 4 items
时间窗: baseline
rating scale
score of Patient Health Questionnare, PHQ-9
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Scale for Suicide Ideation，SSI
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
Hypomania Check List,HCL-33
时间窗: 6th weekend±14days,
rating scale
Big 5 Personality Questionnaire， B5PQ
时间窗: baseline
rating scale
score of Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
时间窗: 2nd weekend±7days
EEG features
Eye movement features extracted by machine learning
时间窗: Week 14-104 Every 4 weekends ± 14 days
Eye movement features extracted by machine learning
Sheehan Disability Scale，SDS
时间窗: 6th weekend±14days,
rating scale
Interpersonal Reactivity Index-C
时间窗: 6th weekend±14days,
rating scale
Hamilton Depression Rating Scale for Depression - 17-item，HAMD-17
时间窗: 6th weekend±14days,
rating scale
score of Generalized Anxiety Disorder,GAD-7
时间窗: 12th weekend±14days,
rating scale
score of Hypomania Check List,HCL-33
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Interpersonal Reactivity Index-C
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
score of Hamilton Anxiety Scale，HAMA
时间窗: Week 14-104 Every 4 weekends ± 14 days
rating scale
average power of 4 bands: δ (1-4 Hz)、 θ (4-8 Hz)、 α (8-13 Hz)、 β (13-30 Hz)
时间窗: Week 14-104 Every 4 weekends ± 14 days
EEG features
1.Average duration of EEG microstates 2. The average number of occurrences of EEG microstates per second 3. Average percentage of time covered by EEG microstates 4.the calculation of microstate transition.
时间窗: Week 14-104 Every 4 weekends ± 14 days
EEG features
Connectivity index of full-band brain function network, and connectivity index of each band brain function network
时间窗: Week 14-104 Every 4 weekends ± 14 days
EEG features
EEG features extracted by machine learning
时间窗: Week 14-104 Every 4 weekends ± 14 days
EEG features
Eye movement index
时间窗: Week 14-104 Every 4 weekends ± 14 days
Collect resting eye movement data and task eye movement data. For eye movement data, features are extracted from blinking, scanning, staring, pupil diameter, initial fixation latency, initial fixation duration, total fixation duration and area of interest and so on.
次要结局
未报告次要终点
研究者
Yanhui Liao
Major Investigators
Sir Run Run Shaw Hospital