The Role of Neuromodulators in Refractory Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

Short-term and Low-dose Application of Neuromodulators Increases Treatment Efficacy and Minimizes Antidepressant Discontinuation Syndrome in Refractory Functional Dyspepsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099913
• Other study ID #: RJYYXHNK
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2022
• Source: RenJi Hospital
• Contact: Shengliang Chen, PhD
• Phone: 13916084817
• Email: chensl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 30, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antidepressant Drug Adverse Reaction
• Digestive System Diseases
• Drug-Related Side Effects and Adverse Reactions
• Dyspepsia
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Syndrome

Intervention

Drug:
• Deanxit
Central neuromodulators was applied in refractory FD patients for different time

Locations

Country	Name	City	State
China	Shengliang Chen	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Fava GA, Cosci F. Understanding and Managing Withdrawal Syndromes After Discontinuation of Antidepressant Drugs. J Clin Psychiatry. 2019 Nov 26;80(6). pii: 19com12794. doi: 10.4088/JCP.19com12794. — View Citation

Fava GA, Gatti A, Belaise C, Guidi J, Offidani E. Withdrawal Symptoms after Selective Serotonin Reuptake Inhibitor Discontinuation: A Systematic Review. Psychother Psychosom. 2015;84(2):72-81. Epub 2015 Feb 21. — View Citation

Luo L, Du L, Shen J, Cen M, Dai N. Benefit of small dose antidepressants for functional dyspepsia: Experience from a tertiary center in eastern China. Medicine (Baltimore). 2019 Oct;98(41):e17501. doi: 10.1097/MD.0000000000017501. — View Citation

Wang L, Zhong Z, Hu J, Rong X, Liu J, Xiao S, Liu Z. Sertraline plus deanxit to treat patients with depression and anxiety in chronic somatic diseases: a randomized controlled trial. BMC Psychiatry. 2015 Apr 14;15:84. doi: 10.1186/s12888-015-0449-2. — View Citation

Yu YY, Fang DC, Fan LL, Chang H, Wu ZL, Cao Y, Lan CH. Efficacy and safety of esomeprazole with flupentixol/melitracen in treating gastroesophageal reflux disease patients with emotional disorders. J Gastroenterol Hepatol. 2014 Jun;29(6):1200-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks and 4 weeks
Primary	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.	2 weeks and 4 weeks
Primary	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.	2 weeks and 4 weeks
Secondary	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.	1 week