The Role of Neuromodulators in Refractory Functional Dyspepsia

RenJi Hospital220 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Dyspepsia Functional Gastrointestinal Disorders Antidepressant Discontinuation Syndrome Antidepressant Drug Adverse Reaction

Interventions

DeanxitDRUG

Central neuromodulators was applied in refractory FD patients for different time

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shengliang Chen

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.

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.

Time frame: 2 weeks and 4 weeks

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.

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.

Time frame: 2 weeks and 4 weeks

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.

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.

Time frame: 2 weeks and 4 weeks

Secondary Outcomes

Antidepressants discontinuation syndrome was recorded.

Rate of patients with dicscontinuation symdrome including headache, insomia, or flu-like reactions was obtained after antidepressant withdrawal within 1 week.

Time frame: 1 week

Central Contacts

Shengliang Chen, PhD

CONTACT

13916084817 chensl@163.com

Data from ClinicalTrials.gov

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