研究疾病:
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抑郁症
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研究疾病代码:
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Target disease:
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Depression
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Target disease code:
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研究类型:
Study type:
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观察性研究
Observational study
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研究设计:
Study design:
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析因分组(即根据危险因素或暴露因素分组)
Factorial
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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利用AI技术深度分析抑郁症患者的舌象特征用以预测潜在的抑郁人群,探索通过舌象医疗大数据与人工智能技术的融合,实现大学生抑郁症防治由“筛查”到“预警”的转变;同时,通过运动疗法对抑郁症患者进行干预并结合运动干预前后受试者肠道菌群变化和抑郁自评量表(SDS)结果对比分析运动干预对改善患者抑郁情况的影响。
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Objectives of Study:
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Using AI analytical technology to deeply analyse the patients tongue characteristics for detecting college students potentially with depression, and explore to shift the prevention and treatment of depression from "screening" to "warning" by integrating the big medical datasets of the tongue's characteristics and artificial intelligence technology. Meanwhile, exercise treatment is used as an intervention to the patients and analysis will be conducted to study the effect of the exercise intervention for improving the patients derpession syndromes by comparing their intestinal flora and the results of SDS before and after the intervention.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1.年龄在18岁及以上;
2.符合国际通用的美国精神障碍诊断与统计手册(DSM-5)诊断标准:
在2周时间内,出现5个或者以上的下列症状,其中至少1项是心境抑郁或丧失兴趣愉悦感:①几乎每天大部分时间都是心境抑郁,既可以是主观报告(例如感到悲伤、空虚、无望),也可以是他人的观察(如表现流泪)(注:儿童和青少年,可能表现为心境易激惹);②几乎每天或每天的大部分时间,对于所有或几乎所有的活动兴趣或乐趣都明显减少(既可以是主观体验,也可以是观察所见);③体重明显下降(未节食)或体重增加(1个月内体重变化超过原体重的5%),或几乎每天食欲都减退或增加;④几乎每天都失眠或睡眠过多;⑤几乎每天都精神运动性激越或迟滞(由他人观察所见,而不仅仅是主观体验到的坐立不安或迟钝);⑥几乎每天都疲劳或精力不足;⑦几乎每天都感到自己毫无价值,或过分的、不适当的感到内疚(可以达到妄想的程度),并不仅仅是因为患病而自责或内疚;⑧几乎每天都存在思考或注意力集中的能力减退或犹豫不决(既可以是主观的体验,也可以是他人的观察);⑨反复想到死亡(不只是怕死),反复出现没有特定计划的自杀意念,或有某种自杀企图,或有某种实施自杀的特定计划。基线资料(年龄、性别等)具有可比性;
3.症状引起有临床意义的痛苦,或导致社交、职业其他重要功能方面的损害;
4.症状不能归因于某种物质的生理效应,或其他躯体疾病(1和3构成了重性抑郁发作);
5.这些重性抑郁发作的出现不能更好地用分裂情感性障碍、精神分裂症、妄想障碍,或其他特征的或未特定的精神分裂症谱系及其他精神病性障碍来解释;
6.从未有躁狂发作或轻躁狂发作(若所有躁狂样或轻躁狂样发作都是由物质滥用所致的,或归因于其他疾病的生理效应,则此排除条款不适用);
7.12小时内抑郁自评量表(SDS)标准分(Y)在53分—62分范围内(包含53分及62分);
8.知情同意,签署知情同意书,并自愿受试。
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Inclusion criteria
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1. Aged 18 and above;
2. Accord with the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5):
Over a period of two weeks, five or more of the following symptoms appear, at least one of which is mood depression or the loss of interest and pleasure:①Mood depression occurs most of the day which can either be reported subjectively (feeling sad, empty, hopeless,etc.) or observed by others.(acting tearful ,etc.) (For children and adolescents, it may also present as mood irritability.); ②Almost for every day or most of the day, there is a marked decrease in interest or pleasure in all or most of daily activities which can be either reported subjectively or observed by others; ③Significant weight loss (not dieting) or weight gain (more than 5% of original body weight within a month), or loss or increase of appetite almost everyday; ④Appear insomnia or sleep too much almost every day; ⑤Psychomotor agitation or lethargy (observed by others, not just merely subjective experience of restlessness or dullness) appears almost every day; ⑥Feeling fatigue or lack of energy almost every day; ⑦Feeling worthless nearly for everyday, or feeling excessively and unduly guilty (even to the level of delusion), which is not just self-reproach or guilt for being ill; ⑧Indecision or the decrease of ability to think or concentrate appear nearly everyday which can either be reported subjectively or observed by others. ⑨Recurred thoughts of death (not just the fear of death), repeated suicidal ideations with no specific plan, or some kind of suicide attempt, or some kind of specific plan to commit suicide. Baseline data (age, sex, etc.) are comparable;
3. The symptoms mentioned above has caused clinically significant pain or impairment of social or professional functions;
4. The symptoms can not be attributed to the physiological effect of a substance, or other body diseases (1 and 3 constitutes a major depressive episode);
5. The occurrence of these major depressive episodes can not be better explained as schizoaffective disorder, schizophrenia, delusional disorder, or any other characteristic or unspecified schizophrenia spectrum or psychotic disorder;
6. Never appear a manic or hypomanic episode. (This exclusion does not apply if all manic or hypomanic episodes are caused by substance abuse or are attributable to the physical effects of another medical condition.);
7. The standard score (Y) of the Self-Rating Depression Scale (SDS) within 12 hours ranged from 53 points to 62 points (including 53 points and 62 points);
8. Informed consent, signed the informed consent, and is volunteered to take the test.
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排除标准:
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1.有自杀倾向者或依从性差,无法配合采样者;
2.正在使用抗抑郁药物治疗者;
3.染苔、刮过舌苔以及伸舌困难者;
4.合并精神分裂症或其他精神性障碍住院患者;
5.合并严重内科疾病、肿瘤或中枢神经系统器质性病变者;
6.器质性抑郁症患者;
7.患有双相情感障碍者;
8.患有如急慢性肠炎、溃疡性结肠炎、肠癌、克罗恩病、肠结核、肠伤寒、缺血性肠病、结肠或直肠息肉、结肠或直肠恶性肿瘤等可能会引起肠道菌群结构紊乱的急慢性肠道疾病者;
9.入组前出现具有临床意义的异常体格检查结果,根据研究者的判断,将影响本研究目的的达成或妨碍实现对研究程序的依从性者。
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Exclusion criteria:
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1. People with suicidal tendencies or poor compliance who are unable to cooperate with the sampling;
2. People who are taking antidepressant medication;
3. People who have stained tongue coating or have scratched their tongue coating or hard to extend their tongue;
4. Inpatients with schizophrenia or other psychiatric disorders;
5. People With severe internal medicine diseases, tumors, or organic disease of the central nervous system;
6. Patients with organic depression;
7. Patients with bipolar disorder;
8. People with acute or chronic intestinal diseases such as acute or chronic enteritis, ulcerative colitis, intestinal cancer, Crohn's disease, intestinal tuberculosis, enteric typhoid fever, ischemic bowel disease, colon or rectal polyps, or colon or rectal malignancies that has the potential to cause the disorder of intestinal flora structure;
9.Patients with clinically significant abnormal physical examination results before enrollment, which, according to the investigator's judgment, will affect the achievement of the purpose of the study or hinder the implementation of compliance with the study procedures.
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研究实施时间:
Study execute time:
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从From
2021-07-15
至To
2022-07-15
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征募观察对象时间:
Recruiting time:
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从From
2021-07-15
至To
2021-08-15
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