Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Cohort Study of Obsessive-Compulsive Disorder

10 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline in Beck Depression Inventory-Second Edition (BDI-II) total score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Mental Health Center

Onderzoekers

  • Hoofdonderzoeker: Qing Zhao, Shanghai Mental Health Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 september 2026

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

8 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

10 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-SFDL06

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren