이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Cohort Study of Obsessive-Compulsive Disorder

2026년 9월 10일 업데이트: Qing ZHAO, Shanghai Mental Health Center

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.

연구 개요

상태

아직 모집하지 않음

정황

강박 장애

연구 유형

관찰

등록 (추정된)

500

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Qing Zhao
전화번호: +86 18516539730
이메일: zhaoqing@smhc.org.cn

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Participants will be recruited from clinical outpatient and inpatient units at Shanghai Mental Health Center. The study population consists of adult patients diagnosed with obsessive-compulsive disorder seeking routine clinical care. No investigator-assigned treatments are provided.

설명

Inclusion Criteria:

【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.

Exclusion Criteria:

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

그룹/코호트

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score 기간: 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.	Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up

2차 결과 측정

결과 측정	측정값 설명	기간
Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) total score 기간: 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 revised by Beck et al. and is a self-assessment tool used to evaluate the degree of depression. It consists of 21 items and is used to assess the severity of depressive symptoms. This scale uses a four-point rating system from 0 to 3. The total score ranges from 0 to 13 indicating no depression, 14 to 19 indicating mild depression, 20 to 28 indicating moderate depression, and 29 to 63 indicating severe depression.	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 기간: 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 Beck et al. It consists of 21 items, each of which is rated on a scale of 0 to 3, representing four levels. It is a self-assessment tool for evaluating anxiety symptoms. The total score is the sum of all items, with a score range of 0 to 63. The higher the score, the more severe the anxiety. A total score of 15-25 indicates mild anxiety, 26-35 indicates moderate anxiety, and above 36 indicates severe anxiety. The Chinese version of this scale has good reliability and validity and is widely used in the assessment of anxiety symptoms.	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 기간: From study baseline until the end of study follow-up (variable follow-up duration across participants)	Adverse events prospectively captured during follow-up are documented, includes adverse events that may occur during the actual phamachotherapy treatment process of the research participants, as well as during psychological treatment or other intervention studies. During the research, the occurrence time, manifestation form, severity, handling measures, and outcome of the adverse events will be recorded.Each participant is counted once if one or more adverse events newly occur after study enrolment, regardless of total event episodes. Data will be summarized using participant counts and corresponding proportions.	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) 기간: From study baseline until the end of study follow-up (variable follow-up duration across participants)	Suicidal-related events include suicidal ideation, non-suicidal self-harm and suicide attempts, identified using the C-SSRS structured interview. A participant will be counted only once if one or more suicidal-related events newly occur after study enrolment during follow-up, regardless of total event episodes. Data will be summarized as participant counts and corresponding proportions.	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 기간: From study baseline until the end of study follow-up (variable follow-up duration across participants)	Serious adverse events are defined according to ICH-GCP criteria. Events are documented using verbatim clinical descriptions obtained from study follow-up interviews. A participant will be counted only once if any serious adverse event occurs during follow-up, irrespective of the total number of individual events experienced. Only serious adverse events newly occurring after study enrolment are counted. Data will be summarized as participant counts and corresponding proportions.	From study baseline until the end of study follow-up (variable follow-up duration across participants)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Shanghai Mental Health Center

수사관

수석 연구원: Qing Zhao, Shanghai Mental Health Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 15일

기본 완료 (추정된)

2030년 12월 31일

연구 완료 (추정된)

2030년 12월 31일

연구 등록 날짜

최초 제출

2026년 9월 8일

QC 기준을 충족하는 최초 제출

2026년 9월 10일

처음 게시됨 (실제)

2026년 9월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)