NCT06788444 Efficacy of Esketamine for Patients With Irritable Bowel Syndrome
| NCT ID | NCT06788444 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 552 participants |
| Start Date | 2025-09-18 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).
Eligibility Criteria
Inclusion Criteria: 1. Age of 18 - 60 years; 2. American Society of Anesthesiologists (ASA) physical status of I - II; 3. Body Mass Index (BMI) of 15 - 30; 4. Scheduled for colonoscopy; 5. Positive screening results according to the Rome IV diagnostic criteria for IBS; 6. Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (MDD) . Exclusion Criteria: 1. GastrointestinalTract (GI) bleeding; 2. Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy; 3. A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease; 4. A history of weight loss (at least 10%) within six months; 5. A history of abdominal surgery (other than hernia repair or appendectomy); 6. Participate in other clinical trials within 3 months; 7. Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years; 8. Mental disorde