Short-term and Low-dose Application of Neuromodulators Increases Treatment Efficacy and Minimizes Antidepressant Discontinuation Syndrome in Refractory Functional Dyspepsia
Sponsor study identifier
interventional
220
1 country
1
Study Start
August 1, 2020
Actual (reported)Primary Completion
October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2020
Actual (reported)September 23, 2021
Actual (reported)October 29, 2021
Actual (reported)October 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Antidepressants discontinuation syndrome was recorded.
1 week
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).
Central neuromodulators was applied in refractory FD patients for different time
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shengliang Chen
Shanghai, 200001, China
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.
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.
First Submitted
September 23, 2021
First Posted
October 29, 2021
Study Start
August 1, 2020
Actual (reported)Primary Completion
October 1, 2022
Estimated (date passed)SMS Reminders and Treatment Compliance and Efficacy in Patients With FGIDs
Contact the study team to confirm eligibility.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 31, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: