The Role of Neuromodulators in Refractory Functional Dyspepsia

NCT05099913 | Unknown DMC

• 1 other identifier: RJYYXHNK
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyspepsia; Functional Gastrointestinal Disorders; Antidepressant Discontinuation Syndrome; Antidepressant Drug Adverse Reaction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Antidepressants discontinuation syndrome was recorded.

  1 week

Study Arms (2)

2-week group

EXPERIMENTAL

Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand.

Drug: Deanxit

4-week group

EXPERIMENTAL

Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).

Drug: Deanxit

Interventions

Deanxit DRUG

Central neuromodulators was applied in refractory FD patients for different time

Also known as: Flupentixol and Melitracen

2-week group; 4-week group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shengliang Chen

Shanghai, 200001, China

RECRUITING

Related Publications (6)

• 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. doi: 10.1111/jgh.12552.

  PMID: 24955450 RESULT

• 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.

  PMID: 25879863 RESULT

• 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.

  PMID: 31593119 RESULT

• 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. doi: 10.1159/000370338. Epub 2015 Feb 21.

  PMID: 25721705 RESULT

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

  PMID: 31774947 RESULT

• Wang QQ, Cheng L, Wu BY, Xu P, Qiu HY, Wang B, Yan XJ, Chen SL. Short-course antidepressant therapy reduces discontinuation syndrome while maintaining treatment efficacy in patients with refractory functional dyspepsia: A randomized controlled trial. Front Psychiatry. 2022 Dec 8;13:1063722. doi: 10.3389/fpsyt.2022.1063722. eCollection 2022.

  PMID: 36569610 DERIVED

MeSH Terms

Conditions

Dyspepsia; Gastrointestinal Diseases

Interventions

flupentixol, melitracen drug combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Central Study Contacts

Shengliang Chen, PhD

CONTACT

13916084817; chensl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor, chief physician

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 29, 2021
• Study Start: August 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 30, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)