Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment1600 (estimated)
SponsorShanghai Mental Health Center
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 22, 2020
Main results expectedJune 30, 2027
Study endsDecember 31, 2028
Registry record updatedMay 15, 2025
Trial IDNCT04539951 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.