The Role of Neuromodulators in Refractory Functional Dyspepsia

Not Applicable

• Conditions: Functional Gastrointestinal Disorders; Dyspepsia; Antidepressant Discontinuation Syndrome; Antidepressant Drug Adverse Reaction
• Interventions: Drug: Deanxit

• Registration Number: NCT05099913
• Lead Sponsor: RenJi Hospital

Brief Summary

The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia

Detailed Description

Functional dyspepsia (FD) is a prevalent disease combined with emotional disorders. Antidepressants are beneficial in the treatment of refractory FD, while for the long-term use of antidepressants, it could lead to withdrawal syndrome or other adverse events.

Refractory FD patients were unsatisfied with the regular first-line anti-acid treatment. However, many patients were worried about taking antidiepressants, even though guideline has recommended antidepressant use in FD. In our study, we would use low-dose and short-term antidepressant in refractory FD patients, and investigate whether short-term antidepressants application would improve therapeutic efficacy and minimize antidepressant withdrawal of FD patients.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-29
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• 18-70 years old;
• education level higher than middle school;
• met the Rome IV criteria for FD; absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
• absence of Helicobacter pylori infection;
• signed written informed consent for participation in the study.

Exclusion Criteria

• evidence of organic digestive diseases;
• diabetes, cancer and other diseases might affect GI function;
• pregnancy, lactation or breastfeeding;
• a history of allergic reaction to any of the drugs used in the study;
• participation in other clinical trials in the previous 3 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-week group	Deanxit	Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand.
4-week group	Deanxit	Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).

Primary Outcome Measures

Name	Time	Method
Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.	2 weeks and 4 weeks	The LDQ scores of 0-4 were classified as very mild dyspepsia, 5-8 as mild dyspepsia, 9-15 as moderate dyspepsia, and \>15 as severe or very severe dyspepsia.
Changes from baseline Patient Health Questionaire-9 (PHQ-9) scores at 2 weeks and 4 weeks was obtained to assess the depression contition after treatment.	2 weeks and 4 weeks	The PHQ-9 scores of 0-4 were classified as none or minimal depression, 5-9 as mild, 10-14 as moderate, 15-19 as moderately severe, and ≥20 as severe depression.
Changes from baseline Generalized Anxiety Questonaire-7 (GAD-7) scores at 2 weeks and 4 weeks were obtained to assess the anxiety contition after treatment.	2 weeks and 4 weeks	The GAD-7 scores of 0-4 were classified as the absence of anxiety, 5-9 as mild, 10-14 as moderate, and ≥15 as severe.

Secondary Outcome Measures

Name	Time	Method
Antidepressants discontinuation syndrome was recorded.	1 week	Rate of patients with dicscontinuation symdrome including headache, insomia, or flu-like reactions was obtained after antidepressant withdrawal within 1 week.

Trial Locations

Locations (1)

Shengliang Chen; 🇨🇳 Shanghai, China