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Not yet recruitingNCT07822516Updated Sep 16, 2026

Cohort Study of Obsessive-Compulsive Disorder

An observational study in Obsessive - Compulsive Disorder, sponsored by Shanghai Mental Health Center. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Shanghai Mental Health Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 60 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Obsessive - Compulsive Disorder

Keywords

  • Obsessive compulsive disorder
  • Prospective Cohort Study
  • Longitudinal Study
  • Clinical Subgroup
03

In context

Obsessive-Compulsive Disorder

635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.

This study's planned enrollment of 500 is above the median of 133 across 86 observational studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

【First-episode obsessive-compulsive disorder subgroup】

  • Aged 18-60 years, no restriction on sex;
  • Meets 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 . 【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

Exclusion Criteria:

  • Meets the diagnosis criteria in 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score

    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.

    Time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up

Secondary outcomes

  1. Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) total score

    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.

    Time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up

  2. Change from baseline in Beck Anxiety Inventory (BAI) total score

    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.

    Time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up

  3. Number of participants experiencing any adverse event identified via participant follow-up interview

    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.

    Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)

  4. Number of participants with suicidal-related events assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    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.

    Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)

  5. Number of participants experiencing serious adverse events identified via participant follow-up interview

    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.

    Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07822516
Responsible party
Qing ZHAO (Attending psychiatrist, Shanghai Mental Health Center) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 16, 2026

Study contacts

Qing Zhao
Contact
zhaoqing@smhc.org.cn
+86 18516539730
Qing Zhao
principal investigator · Shanghai Mental Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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