Evaluating treatment options for Obsessive-Compulsive Disorder
Official title: A Pragmatic Trial of Pharmacotherapy Options Following Unsatisfactory Initial Treatment in OCD
Run by Shanghai Mental Health Center · NCT04539951 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | September 22, 2020 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | May 15, 2025 |
| Trial ID | NCT04539951 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe comorbid psychiatric disorders or those at high risk of suicide may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown varying success with similar pharmacotherapy approaches, but this trial aims to provide more comprehensive real-world data.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Low-intensity focused ultrasound targeting the subthalamic nucleus for OCD
A short test is being done to see if a wearable, non-invasive ultrasound device can safely and tolerably help adults with OCD by targeting a brain region called the subthalamic nucleus.
-
Mindfulness-Based Cognitive Therapy for OCD Delivered Online
This study tests a synchronous online MBCT program for adults with OCD to see if it is acceptable and feasible and to explore links between biological markers, OCD severity, and treatment response.
-
Targeted brain stimulation for OCD: test of tTIS on nucleus accumbens
This study tests whether targeted temporal interference stimulation of the nucleus accumbens can help reduce obsessive-compulsive symptoms in adults with OCD, compared with sham stimulation.
-
Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety
This study tests whether a brief video-based skill training can help people with anxiety as well as four therapy sessions, and how durable the effects are over a year.
-
AttunE LIFU for OCD: a non-invasive brain stimulation study
This trial tests ATTN201, a wearable ultrasound headband, to see if it helps adults with OCD compared to a sham treatment.
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Combined ERP and Habit Reversal Therapy for Tourettic OCD
This study tests whether a merged Exposure and Response Prevention and Habit Reversal Therapy helps adults with Tourettic OCD more than either therapy alone or basic psychoeducation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.