Cohort Study of Obsessive-Compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score
研究概览
简要总结
This study will establish a standardized, multi-dimensional prospective longitudinal cohort for obsessive-compulsive disorder. It seeks to explore differences in symptom trajectories, functional trajectories, treatment responses, and long-term outcomes among different OCD clinical subgroups. Additionally, it will examine whether multi-modal measures (including clinical features, neuropsychological tests, neuroimaging, electroencephalography (EEG), magnetoencephalography (MEG), functional near-infrared spectroscopy (fNIRS), and blood and stool biospecimens) can explain clinical heterogeneity and predict treatment response and long-term prognosis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •【First-episode obsessive-compulsive disorder subgroup】
- •Aged 18-60 years, no restriction on sex;
- •Meets DSM-5 diagnostic criteria for obsessive-compulsive disorder;
- •Junior high-school education or above; able to understand study-related information and complete questionnaires and examinations;
- •Has never received pharmacotherapy, psychological therapy or physical intervention for OCD;
- •Voluntarily participates in this study and provides written informed consent. 【Initial-treatment non-responder subgroup】
- •Aged 18-60 years, no restriction on sex;
- •Meets DSM-5 diagnostic criteria for obsessive-compulsive disorder;
- •Junior high-school education or above; able to understand study-related information and complete questionnaires and examinations;
- •Has shown poor treatment response or intolerance after adequate-dose and adequate-duration treatment with one SSRI/SNRI agent, OR after receiving 12 sessions of cognitive-behavioral therapy (CBT);
- •Voluntarily participates in this study and provides written informed consent. 【Pharmacotherapy-resistant subgroup】
- •Aged 18-60 years, no restriction on sex;
- •Meets DSM-5 diagnostic criteria for obsessive-compulsive disorder;
- •Junior high-school education or above; able to understand study-related information and complete questionnaires and examinations;
- •Demonstrates poor treatment response or intolerance following adequate-dose and adequate-duration treatment with two or more different SSRI/SNRI agents;
- •Voluntarily participates in this study and provides written informed consent.
排除标准
- •Meets the diagnosis criteria in DSM-5 except for obsessive-compulsive disorder (excluding obsessive-compulsive personality disorder);
- •The obsessive symptoms are severe and prevent the patient from completing the required assessment tests;
- •Pregnant or women who are about to become pregnant, lactating women;
- •Have severe negative thoughts or a high risk of suicide;
- •Have a history of other substance dependence or excessive use in the past year; 6) Other situations deemed unsuitable for inclusion by the researchers.
研究组 & 干预措施
Obsessive-Compulsive Disorder Participants
This is a prospective, observational, longitudinal disease-specific cohort study for obsessive-compulsive disorder. This cohort contains first-episode obsessive-compulsive disorder, initial-treatment non-responders, and pharmacotherapy-resistant obsessive-compulsive disorder.No additional research-based randomization will be performed, and no therapeutic interventions will be assigned by investigators. After completing baseline assessments, participants with obsessive-compulsive disorder will enter longitudinal follow-up. After the first-year follow-up, participants will be followed-up every six-months for a total follow-up duration of 5 years. Collected data encompass clinical information and rating scales, biospecimens (blood, stool), neuropsychological tests, MRI, electroencephalography, functional near-infrared spectroscopy (fNIRS), eye-movement tests, and magnetoencephalography. Participants are permitted to enroll in optional nested sub-studies.
结局指标
主要结局
Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score
时间窗: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up
This scale was developed by Goodman et al. It is a widely used self-assessment tool for obsessive-compulsive symptoms both domestically and internationally, consisting of 10 items and 42 sub-items. The scale employs a 5-point rating system ranging from 0 to 4. The total score ranges from 0 to 40. The higher the score, the more severe the obsessive-compulsive symptoms. A total score of 8-15 indicates mild obsessive-compulsive symptoms, 16-25 indicates moderate symptoms, and a score above 25 indicates severe symptoms. Its Chinese version was introduced and validated for reliability and validity by our research group, and has been extensively adopted in both clinical practice and research settings. In the present study, Y-BOCS scores will be applied for participant screening at enrollment, and will also serve as an assessment tool for symptom severity during follow-up visits.
次要结局
- Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) total score(Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up)
- Change from baseline in Beck Anxiety Inventory (BAI) total score(Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up)
- Number of participants experiencing any adverse event identified via participant follow-up interview(From study baseline until the end of study follow-up (variable follow-up duration across participants))
- Number of participants with suicidal-related events assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)(From study baseline until the end of study follow-up (variable follow-up duration across participants))
- Number of participants experiencing serious adverse events identified via participant follow-up interview(From study baseline until the end of study follow-up (variable follow-up duration across participants))
研究者
Qing ZHAO
Attending psychiatrist
Shanghai Mental Health Center