← Back to all trials
Recruiting
NCT06788444
Efficacy of Esketamine for Patients With Irritable Bowel Syndrome
Conditions: Irritable Bowel Syndrome
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 552
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tiantan Hospital Beijing Beijing Municipality
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 disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;
9. Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;
10. Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;
11. Pregnancy or breastfeeding.
Source: ClinicalTrials.gov (NCT06788444). StuddyBuddy aggregates publicly available trial information.