NCT04539951 Pragmatic Trial of Obsessive-compulsive Disorder
| NCT ID | NCT04539951 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Mental Health Center |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2020-09-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,600 participants in total. It began in 2020-09-22 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study includes a sequenced clinical trial in order to assess the efficacy of several switching or augment strategies when initial treatment is ineffective，and to provide strong evidence for clinical practice and international guidelines for Obsessive-Compulsive Disorder treatments.
Eligibility Criteria
Inclusion criteria:They * meet DSM-5 diagnostic criteria for OCD as the primary diagnosis ; * are in the age range from 18 to 65 years; * have a score of at least 20 on Yale-Brown Obsessive-Compulsive Scale (Y-BOCS); * have never received medication for OCD, and have not received any form of psychotherapy for OCD in the past 1 month; * have provided written informed consent. exclusion criteria: They * have met the DSM-5 diagnostic criteria for Schizophrenia Spectrum and Other Psychotic Disorders, or the Bipolar and Related Disorders; * have a moderate or higher risk of suicide (⩾9 on the Suicide Module in the Mini-International Neuropsychiatric Interview (MINI)); * have substance use that is sufficiently severe to possibly impact negatively on treatment adherence in the past 1 year; * have severe depression with Beck Depression Inventory (BDI) score of ≥29; * have comorbid psychiatric or medical disorders that may impact negatively on adherence to or on the efficacy of medication (eg borderline personality disorder, CNS disorders)； * are pregnant or lactating females.
Contact & Investigator
Zhen Wang, PhD,MD
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT04539951 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04539951 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04539951 currently recruiting?
Yes, NCT04539951 is actively recruiting participants. Contact the research team at wangzhen@smhc.org.cn for enrollment information.
Where is the NCT04539951 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04539951 clinical trial?
NCT04539951 is sponsored by Shanghai Mental Health Center. The principal investigator is Zhen Wang, PhD,MD at Shanghai Mental Health Center. The trial plans to enroll 1,600 participants.