Obsessive - Compulsive DisorderNCT07822516
Cohort Study of Obsessive-Compulsive Disorder
An observational study of Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive - Compulsive Disorder
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 【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】
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- Obsessive compulsive disorder, Prospective Cohort Study, Longitudinal Study, Clinical Subgroup
- Medical subject headings
- Compulsive Personality Disorder, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up
Secondary outcomes (5)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: From study baseline until the end of study follow-up (variable follow-up duration across participants)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing ZHAO, Shanghai Mental Health Center
- Investigators
- Qing Zhao, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822516
- Sponsor's protocol ID
- 2025-SFDL06
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT07822516
- Acronym / sponsor ID
- 2025-SFDL06
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- Obsessive compulsive disorder, Prospective Cohort Study, Longitudinal Study, Clinical Subgroup
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (16 listed)
- 【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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score
Time frame: 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.
5 secondary outcomes
Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) total score
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: From study baseline until the end of study follow-up (variable follow-up duration across participants)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qing Zhao principal investigator
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive - Compulsive Disorder, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Zhao (+86 18516539730, zhaoqing@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score (time frame: Baseline, 8-week, 12-week, 6-month, 9-month, 12-month, every 6-months thereafter up to total 5-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.