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Cohort Study of Obsessive-Compulsive Disorder

2026年9月10日 更新者：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.

調査の概要

状態

まだ募集していません

条件

研究の種類

観察的

入学 (推定)

500

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) total score
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Shanghai Mental Health Center

捜査官

  • 主任研究者：Qing Zhao、Shanghai Mental Health Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月15日

一次修了 (推定)

2030年12月31日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2026年9月8日

QC基準を満たした最初の提出物

2026年9月10日

最初の投稿 (実際)

2026年9月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16日

QC基準を満たした最後の更新が送信されました

2026年9月10日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-SFDL06

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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