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谱优化光线对重度抑郁障碍认知障碍的疗效及其神经影像机制

2026年7月2日 更新者：Xiaozhen LV、Peking University Sixth Hospital

光谱优化光对重度抑郁障碍认知障碍的疗效及其神经影像机制研究

本研究旨在验证光谱优化光（SOL）在改善重度抑郁症（MDD）患者认知障碍（CI）方面的治疗效果和安全性，表征MDD伴认知障碍患者海马体（HPC）-背外侧前额叶皮层（dlPFC）神经环路的功能和结构特征，并考察HPC-dlPFC神经环路在SOL治疗对MDD-CI患者认知改善中的中介作用。 MDD-CI患者需仅接受选择性5-羟色胺再摄取抑制剂（SSRIs）作为主要药物至少一周或之前未进行任何治疗。 SOL是一种强光疗法（BLT）。 符合条件的参与者将被随机分配至实验组和对照组。 实验组将接受BLT干预，对照组将接受暗红光（安慰剂）干预。 干预将持续四周。 干预期间每周进行一次随访，干预后第四周进行一次随访。 基线时收集人口统计学信息，干预开始后的第2、4、8周末评估认知功能。 抑郁、焦虑和睡眠等其他症状在干预开始后的第1、2、3、4、8周末进行评估。此外，将在基线和干预四周后进行结构和功能磁共振成像扫描。 干预期间，MDD-CI患者需记录每日光照时长，并完成每日睡眠日记。

研究概览

地位

招聘中

条件

干预/治疗

详细说明

本研究设计为一项随机对照研究。 研究聚焦于MDD-CI患者，设立了实验组和对照组。 实验组接受六种SSRIs药物之一治疗，包括氟西汀、帕罗西汀、舍曲林、西酞普兰、氟伏沙明和艾司西酞普兰。 在整个干预期间，药物保持不变。 实验组接受BLT干预，对照组额外接受暗红光（安慰剂）干预。 干预持续四周（每周六天，每天45分钟，时间在上午7点至10点之间）。 干预结束后将在第4周末进行一次随访。 认知评估将在基线、干预开始后第2、4、8周末使用中文版测量共识认知电池（MCCB）、中文简短认知测试（C-BCT）和感知缺陷问卷（PDQ）进行。 其他临床症状将通过17项汉密尔顿抑郁量表（HAMD-17）、汉密尔顿焦虑量表（HAMA）、临床总体印象量表（CGI）、杨氏躁狂评定量表（YMRS）、快速自我评定量表抑郁症状量表（QIDS）、7项广泛性焦虑障碍量表（GAD-7）、匹兹堡睡眠质量指数（PSQI）、中文版生活质量享受与满意度问卷简表（Q-LES-Q-SF）和席汉残疾量表（SDS）在基线、干预开始后第1、2、3、4、8周末进行评估。 同时，使用血清素特异性再摄取抑制剂副作用评定量表（SERS-SSRIs）和治疗依从性记录表调查治疗过程中干预的安全性和适用性。

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Xiaozhen Lv, Ph.D
  • 电话号码：+8601062723705
  • 邮箱：lxz120300@163.com

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100191
        • 招聘中
        • Peking University Sixth Hospital
        • 接触：
    • Shanxi
      • Yanan、Shanxi、中国
        • 招聘中
        • Yan'an Third People's Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

重度抑郁症（MDD）患者的纳入与排除标准。 1、纳入标准：

  1. 符合《精神障碍诊断与统计手册》第五版（DSM-5）对重度抑郁症（首次发作或复发）的诊断标准；
  2. 年龄18-60岁；性别不限；
  3. MDD症状严重程度需满足汉密尔顿抑郁量表17项（HAMD-17）评分＞14分；
  4. 当前存在认知功能障碍，定义为数字符号替换测试（DSST）总分≤70分；
  5. 符合条件患者已接受选择性5-羟色胺再摄取抑制剂（SSRIs）稳定剂量治疗至少1周或未接受治疗；
  6. 小学以上文化程度，能够理解并配合完成研究流程；
  7. 自愿参与本研究，并在入组前签署知情同意书。

2、排除标准：

  1. 根据DSM-5标准，当前或既往患有除重度抑郁症外的任何精神障碍；
  2. 杨氏躁狂评定量表（YMRS）评分＞8分；
  3. 过去六个月内或当前正在接受除SSRIs外的其他干预措施，或计划在一个月内接受此类干预；
  4. 存在强烈自责、自伤或自杀倾向者（HDRS-17自杀项目评分≥3分）；
  5. 患有严重躯体疾病者，包括心力衰竭、肾衰竭、严重肝功能不全、甲状腺功能亢进或减退；或有严重脑外伤史或器质性脑部病变（如脑出血、大面积脑梗死、脑炎、癫痫）及神经系统疾病；
  6. 患有任何程度的视网膜病变，包括视网膜营养不良、年龄相关性黄斑变性、糖尿病视网膜病变、白内障、青光眼或其他眼部疾病；
  7. 存在光敏性疾病者，如系统性红斑狼疮、卟啉病、慢性光化性皮炎、日光性荨麻疹，或当前正在服用可能增加光敏感性的药物（如吩噻嗪类、抗疟药、普萘洛尔、贯叶连翘提取物、兴奋剂或长期使用非甾体抗炎药）；
  8. 妊娠或哺乳期妇女；
  9. 存在磁共振成像（MRI）禁忌症者，如体内有非MRI兼容金属植入物或幽闭恐惧症；
  10. 研究者认为因其他原因不适合参与本研究的个体。

退出与终止标准：

  1. 入组后符合上述任一排除标准；
  2. 当前患者治疗方案需要调整；
  3. 受试者无法配合或自愿退出研究；
  4. 因严重不良事件无法耐受光疗；
  5. 连续三天或累计超过七天未遵循研究方案干预措施；
  6. 研究被取消。

健康对照者的纳入与排除标准

1. 纳入标准

  1. 年龄18-60岁；性别不限；且为右利手；
  2. 当前无认知功能障碍，定义为数字符号替换测试（DSST）总分≤70分；
  3. 小学以上文化程度，能够理解并配合完成研究流程；
  4. 自愿参与本研究，并在入组前签署知情同意书。

2. 排除标准

  1. 当前或终生患有任何精神障碍，或有物质/药物滥用或依赖史；
  2. 当前或既往诊断为严重躯体疾病，如心力衰竭、肾衰竭、严重肝功能不全、甲状腺功能亢进/减退；
  3. 有严重创伤性脑损伤或器质性脑部病变史；
  4. 妊娠或哺乳期妇女；
  5. 存在磁共振成像（MRI）禁忌症者，如体内有非MRI兼容金属植入物或幽闭恐惧症；
  6. 研究者认为因其他原因不适合参与本研究的个体。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：健康控制
安慰剂比较：DRL control group
Eligible MDD participants will be randomly subjected to the DRL control group. The light source intensity will be set at <100 lux and placed 0.6 meters away from the MDD participant. They will be required to staring at the light source for 2 seconds every 5 minutes. The DRL control group will be administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for four weeks, 6 days per week.
设备：DRL
Using a dim red light box as the placebo, with an intensity of <100lux and a main wavelength of 690.4nm
实验性的：BLT experimental group
Eligible MDD participants will be randomly subjected to the BLT experimental group. The source intensity of BLT experimental group will be set at 10000 lux and placed 0.45 meters away from the MDD participant. They will be required to staring at the light source for 2 seconds every 5 minutes. The BLT experimental group will be administered for 40 minutes each day between 7:00 AM and 10:00 AM, lasting for 4 weeks, 6 days per week.
设备：BLT
Using a hybrid white light box with independent intellectual property rights, with an intensity of 10000lux and a main wavelength of 476.4nm

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Symbol Coding (SC)
大体时间：screen, baseline, weeks2, 4, and 8
The Symbol Coding (SC) is a coding paradigm adapted from the Digit Symbol Substitution Test (DSST), both of which use essentially the same method, except in reverse; instead of drawing symbols that match digits, the SC requires to write the matching digit in the blank. The task has been included as a subtest in the Brief Assessment of Cognition in Schizophrenia; in this task, subjects are required to write numerals 1-9 as matches to nonmeaningful symbols on a response sheet for 90 s, as based on a key provided to them, with higher scores reflecting better performance.
screen, baseline, weeks2, 4, and 8

次要结果测量

结果测量
措施说明
大体时间
Hamilton Depression Rating Scale-17（HDRS-17）
大体时间：screen, baseline, weeks1, 2, 3, 4, and 8
The Hamilton Depression Rating Scale-17 (HAMD-17), developed by Hamilton in 1960, is a widely used clinical rating scale consisting of 17 items that evaluate various depressive symptoms, including mood, suicidal thoughts, sleep disturbances, loss of interest, psychomotor changes, anxiety, gastrointestinal and somatic symptoms, sexual dysfunction, and weight loss. Scored on a scale of 0 to 4 (with some items possibly using a 0 to 2 scale), the total score reflects the severity of depressive symptoms and is used for diagnosing depression, planning tailored treatment, monitoring treatment effectiveness, and conducting research on depression treatment efficacy.
screen, baseline, weeks1, 2, 3, 4, and 8
The 20-item Perceived Deficits Questionnaire for Depression（PDQ-D-20）
大体时间：baseline, weeks 2, 4, and 8
The Chinese version of the Perceived Deficits Questionnaire for Depression (PDQ-D) has been validated for reliability and validity among patients with depression in China. The PDQ-D comprises 20 items, yielding a total score that ranges from 0 to 80. Higher scores indicate a greater severity of self-perceived cognitive symptoms. Demonstrating good reliability and validity, the questionnaire assesses patients' cognitive function across four dimensions: attention/concentration, prospective memory, retrospective memory, and planning and organization.
baseline, weeks 2, 4, and 8
The Chinese Brief Cognitive Test（CBCT）
大体时间：baseline, weeks 2, 4, and 8
Cognitive function will be also assessed using the CBCT, which has been validated in a large-scale study of schizophrenia patients and has shown good internal consistency and test-retest reliability. Also, additional studies in MDD population provide further evidence of its reliability and validity supporting the robustness of this scale for assessing cognitive function in these clinical groups.
baseline, weeks 2, 4, and 8
Stroop Color-Word Test (SCWT)
大体时间：baseline, weeks 2, 4, and 8
The Stroop Color Word Test (SCWT) was developed by Professor Stroop in 1935 to evaluate subjects' executive functions. The test is a measure of selective attention and the degree of inhibition of irrelevant information in executive functioning. It consists of three main parts: reading words (Stroop-w), color naming (Stroop-c), and color-word interference (Stroop-cw), which require subjects to accurately and quickly read the words or the colors, respectively, as required.
baseline, weeks 2, 4, and 8
Hopkins Verbal Learning Test-Revised (HVLT-R)
大体时间：baseline, weeks 2, 4, and 8
Hopkins Verbal Learning Test-Revised (HVLT-R) is a widely used neuropsychological assessment tool designed to evaluate verbal memory and cognitive function. Developed by J. Brandt and Benedict in 2001, the HVLT-R consists of a list of 12 nouns divided into three semantic categories (e.g., dwelling places, four-legged animals, and precious stones), with four words per category. The assessment involves three learning trials, where participants are presented with the list of words and are asked to recall as many words as possible immediately after each presentation. Additionally, there is a delayed recall trial, where participants are asked to recall the words after a delay of 20-25 minutes. The scoring principle is based on the number of correctly recalled words during each learning trial and the delayed recall trial. The total score for the three learning trials and the delayed recall trial is calculated as well.
baseline, weeks 2, 4, and 8
Generalized Anxiety Disorder-7（GAD-7）
大体时间：baseline, weeks1, 2, 3, 4, and 8
The Generalized Anxiety Disorder-7 is a standardized assessment tool developed by Spitzer et al. in 2006. It is a 7-item questionnaire designed to evaluate the severity of anxiety symptoms over the past two weeks. The scale covers various aspects of anxiety, including feelings of tension, worry, irritability, and difficulty relaxing. Each item is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms. The GAD-7 is primarily used as a screening and assessment tool in clinical and research settings, aiding clinicians in identifying and quantifying anxiety symptoms, monitoring changes over time, and evaluating treatment effectiveness. It is a simple, reliable, and valid instrument that can be easily administered and scored, making it a valuable addition to the clinical assessment of anxiety disorders.
baseline, weeks1, 2, 3, 4, and 8
Quick Inventory of Depressive Symptomatology-Self-Report（QIDS-SR-16）
大体时间：baseline, weeks1, 2, 3, 4, and 8
The Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), a rigorous and systematic self-assessment scale developed by Rush et al. in 2003 with subsequent refinements, is a widely recognized tool for quickly gauging depressive symptoms over the past week. It comprises 16 items covering various dimensions of depression, including mood, sleep, appetite, energy levels, concentration, self-esteem, suicidal ideation, and daily functioning, each rated on a 4-point scale (0-3). The scale assesses the severity and frequency of symptoms, with higher scores indicating more severe depression. The QIDS-SR16 serves multiple purposes: it aids in screening and assessing depressive symptoms in clinical settings, allows individuals to monitor their depressive state over time, serves as a research tool in clinical studies evaluating treatment effectiveness, and provides valuable information that can support the diagnostic process when combined with clinical interviews.
baseline, weeks1, 2, 3, 4, and 8
Pittsburgh Sleep Quality Inventory（PSQI）
大体时间：baseline, weeks1, 2, 3, 4, and 8
The PSQI, or Pittsburgh Sleep Quality Inventory, was developed by Buysse et al. in 1989. It is a widely used and standardized self-report questionnaire designed to assess sleep quality over the past month. The PSQI consists of 19 self-rated items and 5 additional items for bed partner or roommate ratings (though only 18 of the self-rated items are scored). The assessment covers seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a 0-to-3 scale, with the total PSQI score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with a total score of 5 or less indicating good sleep quality, 6-10 indicating fair sleep quality, 11-15 indicating poor sleep quality, and 16 or more indicating very poor sleep quality. The PSQI serves multiple purposes, including clinical diagnosis of sleep disorders, research on sleep quality, and eval
baseline, weeks1, 2, 3, 4, and 8
Young Mania Rating Scale（YMRS）
大体时间：screen, baseline, weeks1, 2, 3, 4, and 8
The Young Mania Rating Scale (YMRS), developed by R.C. Young and colleagues in 1978, is a clinician-administered rating scale designed to assess the severity of manic symptoms over the past week. It comprises 11 items that evaluate various aspects of mania, including elevated mood, increased activity and energy, sexual interest, sleep pattern, irritability, speech, language-thought disorders, content of thought, aggressive or destructive behavior, appearance, and insight. The scoring system varies across items, with some rated on a 0-4 scale and others on a 0-8 scale. The total score is obtained by summing the ratings of all items, providing a quantitative measure of manic severity. Higher scores indicate more severe manic symptoms. The YMRS is primarily used in clinical and research settings for the assessment of manic states.
screen, baseline, weeks1, 2, 3, 4, and 8
Asberg Side-Effect Rating Scale for Antidepressants (SERS)
大体时间：baseline, weeks1, 2, 3, 4, and 8
Asberg Side-Effect Rating Scale for Antidepressants (SERS) is a rating scale developed by Swedish psychiatrist M. Asberg in 1970. It is specifically designed to evaluate the adverse effects experienced by individuals following the administration of antidepressant medications. The scale contains 14 items that assess a wide range of symptoms, including physical fatigue, dizziness, headache, sleep disturbance, orthostatic hypotension, palpitations, tremors, sweating, dry mouth, constipation, urinary difficulties, somnolence, sexual dysfunction, and other symptoms. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe), allowing for a comprehensive quantification of the severity of side effects. The total score, calculated by summing the ratings of all items, provides an overall measure of antidepressant-related adverse effects. The SERS is primarily used in clinical and research settings to aid in the identification, monitoring, and documentation of side effects.
baseline, weeks1, 2, 3, 4, and 8
Quality of Life Enjoyment and Satisfaction Questionnaire,Short Form（Q-LES-Q-SF）
大体时间：baseline, weeks1, 2, 3, 4, and 8
The Q-LES-Q-SF, developed by Endicott et al. in 1995, consists of 16 items that assess an individual's subjective satisfaction with their quality of life over the past 7 days. The first 14 items reflect various aspects of quality of life, including physical and mental health, mood, work, household responsibilities, social relationships, family relationships, leisure activities, daily living skills, sexual functioning, financial status, living environment, mobility, hobbies, and overall subjective satisfaction with physical and mental health. Items 15 and 16 assess daily medical care and overall life satisfaction. Each item is rated on a scale from 1 to 5, with higher scores indicating better quality of life. The overall score for the Q-LES-Q-SF is derived from the sum of the scores from items 1 to 14.
baseline, weeks1, 2, 3, 4, and 8
Sheehan disability scale (SDS)
大体时间：baseline, weeks1, 2, 3, 4, and 8
The SDS evaluates the impact of depression on a patient's work, social life, and family responsibilities. The total score ranges from 0 to 30, with higher scores indicating greater functional impairment . The SDS has demonstrated strong reliability and validity in depressed populations.
baseline, weeks1, 2, 3, 4, and 8
Hamilton Anxiety Scale (HAMA）
大体时间：Baseline, week 1, 2, 3, 4 and 8
Originally developed by Hamilton in 1959, the HAMA is a classic clinician-administered questionnaire assessing both somatic and psychic anxiety severity. The 14-item instrument captures psychic anxiety (items 1-6, 14) and somatic anxiety (items 7-13). Each item is rated on a 5-point Likert scale from 0 (absent) to 4 (very severe), with higher total scores indicating more severe clinical anxiety. The construct validity and reliability of the Chinese HAMA adaptation have been rigorously established in domestic psychometric studies.
Baseline, week 1, 2, 3, 4 and 8
Insomnia Severity Index (ISI）
大体时间：Baseline, week 1, 2, 3, 4 and 8
The Insomnia Severity Index (ISI) is a standardized tool used to assess the severity of insomnia symptoms and their impact on daily life. It consists of 7 items that encompass difficulties in falling asleep, sleep maintenance, early awakening, satisfaction with sleep, distress caused by symptoms, impairment of daily functioning, and concern about insomnia. Each item is rated on a scale from 0 to 4, with a total score ranging from 0 to 28. A higher score indicates more severe insomnia issues.
Baseline, week 1, 2, 3, 4 and 8
Color Trails Test （CTT）
大体时间：Baseline, week 2, 4 and 8

The Color Trails Test (CTT) (Maj, D'Elia, Satz, Janssen, Zaudig, Uchiyama et al., 1993; D'Elia, Satz, Uchiyama & White, 1996) is a language-free version of the Trail Making Test (TMT) that was developed to allow for broader cross-cultural application to measure sustained attention and divided attention in adults.The CTT is comprised of two tasks: CTT-1 must be administered first and requires the respondent to connect circles in an ascending numbered sequence (1-25).

CTT-2 must follow the CTT1 and requires the respondent to connect numbers in an ascending sequence while alternating between pink and yellow colors. Numbers are presented twice, once in pink and once in yellow, so the client must ignore the distracter item (e.g. start at pink 1, avoid pink 2 to select yellow 2, avoid yellow 3 to select pink 3, etc.).
Baseline, week 2, 4 and 8

其他结果措施

结果测量
措施说明
大体时间
数字符号替换测试（DSST）
大体时间：屏幕
数字符号替换测试（DSST），一项将数字替换为简单符号的编码任务。 该任务涉及注意力、处理速度和执行功能，并已显示出对重度抑郁症（MDD）人群变化的敏感性。22 DSST 分数计算为 90 秒内正确符号的总数（可能得分范围 0-133），分数越高表示表现越好。
屏幕

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Peking University Sixth Hospital

调查人员

  • 首席研究员：Xiaozhen Lv, Ph.D、Peking University Sixth Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月10日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年3月27日

首先提交符合 QC 标准的

2026年3月27日

首次发布 (实际的)

2026年4月2日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 7262156

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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