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The Role of Neuromodulators in Refractory Functional Dyspepsia

Primary Purpose

Dyspepsia, Functional Gastrointestinal Disorders, Antidepressant Discontinuation Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Deanxit
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shengliang ChenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

2-week group

4-week group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2021
Last Updated
March 17, 2022
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05099913
Brief Title
The Role of Neuromodulators in Refractory Functional Dyspepsia
Official Title
Short-term and Low-dose Application of Neuromodulators Increases Treatment Efficacy and Minimizes Antidepressant Discontinuation Syndrome in Refractory Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Functional Gastrointestinal Disorders, Antidepressant Discontinuation Syndrome, Antidepressant Drug Adverse Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2-week group
Arm Type
Experimental
Arm Description
Patients were treated with antidepressants for 10-14 days combined with first-class medication(anti-acid drugs, prokinetics), followed by on demand.
Arm Title
4-week group
Arm Type
Experimental
Arm Description
Patients were treated with antidepressants for 4 weeks combined with first-class medication(anti-acid drugs, prokinetics).
Intervention Type
Drug
Intervention Name(s)
Deanxit
Other Intervention Name(s)
Flupentixol and Melitracen
Intervention Description
Central neuromodulators was applied in refractory FD patients for different time
Primary Outcome Measure Information:
Title
Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.
Description
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
Title
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.
Description
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
Title
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.
Description
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 Outcome Measure Information:
Title
Antidepressants discontinuation syndrome was recorded.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengliang Chen, PhD
Phone
13916084817
Email
chensl@163.com
Facility Information:
Facility Name
Shengliang Chen
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengliang Chen
Phone
02158752345
Email
chenslmd@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24955450
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. doi: 10.1111/jgh.12552.
Results Reference
result
PubMed Identifier
25879863
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.
Results Reference
result
PubMed Identifier
31593119
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.
Results Reference
result
PubMed Identifier
25721705
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. doi: 10.1159/000370338. Epub 2015 Feb 21.
Results Reference
result
PubMed Identifier
31774947
Citation
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.
Results Reference
result

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The Role of Neuromodulators in Refractory Functional Dyspepsia

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