Evaluating treatment options for Obsessive-Compulsive Disorder
A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD
This study is testing different treatment options for people with Obsessive-Compulsive Disorder who didn't get better with the medication sertraline to see what works best for them.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04539951 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of various treatment strategies for patients with Obsessive-Compulsive Disorder (OCD) who do not respond to initial pharmacotherapy with sertraline. The study involves a randomized controlled design across 13 specialized centers, where participants will first receive sertraline for 12 weeks, followed by different treatment options based on their response. The trial aims to provide real-world evidence to guide clinical practice and improve treatment guidelines for OCD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who meet the DSM-5 criteria for OCD and have never received medication or psychotherapy for the condition.
Not a fit: Patients with severe comorbid psychiatric disorders or those at high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with OCD who do not respond to standard therapies.
How similar studies have performed: Previous studies have shown varying success with similar pharmacotherapy approaches, but this trial aims to provide more comprehensive real-world data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Wang, PhD,MD — Shanghai Mental Health Center
- Study coordinator: Zhen Wang, PhD,MD
- Email: wangzhen@smhc.org.cn
- Phone: 862134773516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.