Clinical trial NCT05099913: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspepsia
Functional Gastrointestinal Disorders
Antidepressant Discontinuation Syndrome
Antidepressant Drug Adverse Reaction
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes from baseline Leeds Dyspepsia Questionnaire (LDQ) scores at 2 weeks and 4 weeks were obtained to assess the dyspepsia outcomes.
timeFrame: 2 weeks and 4 weeks
measure: 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.
timeFrame: 2 weeks and 4 weeks
measure: 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.
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: Antidepressants discontinuation syndrome was recorded.
timeFrame: 1 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shengliang Chen
Study officials:
References:
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.
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.
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.
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.
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.