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Study on the difference of therapeutic effect of SSRIs on functional gastrointestinal diseases with anxiety and depression and their correlation with mucosal 5-HT pathway

Study on the difference of therapeutic effect of SSRIs on functional gastrointestinal diseases with anxiety and depression and their correlation with mucosal 5-HT pathway

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050469
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-09-10
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional gastrointestinal disease (FGID)

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent; 2. Aged between 18-65 years, gender is not limited; 3. Able to communicate well with investigators and comply with the entire trial requirements; 4. Meet FD Rome IV diagnostic criteria: disease duration of at least 6 months and one of the following diagnostic criteria for the past 3 months: postprandial fullness, early satiety at least 3 days per week (postprandial discomfort syndrome); upper and middle abdominal pain or burning sensation (at least 1 day per week); 5. FD suffers from anxiety or depression at the same time, generalized anxiety or GAD-7 score >= 5 is divided into anxiety, among them, 5-9 is divided into mild, 10-13 is divided into moderate, 14-18 is divided into moderate to severe, and 19-21 is divided into severe; depression screening scale PHQ-9 score >= 5 is divided into depression, of which 5-9 is mild, 10-14 is moderate, 15-19 is moderate-severe, and 20-27 is severe; 6. Poor response to traditional gastroenterology drugs (acid-suppressing drugs, such as proton pump inhibitors (PPI) or histamine H2 receptor antagonists, antacids, prokinetics, antispasmodics) within half a year.

Exclusion criteria

Exclusion criteria: 1. The presence of organic and metabolic diseases, including severe heart, lung, liver, kidney disease, diabetes, and connective tissue disease, has been confirmed by routine stool and occult blood test, blood biochemistry, abdominal ultrasound, gastroscope and other examinations within the past 1 year; 2. A history of abdominal and/or pelvic surgery; 3. Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
Digestive tract symptoms;Neuropsychiatric symptoms;Objective indicators of neuropsychiatric function;

Countries

China

Contacts

Public ContactLiu Ling

West China Hospital, Sichuan University

18980606772@163.com+86 18980606772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026