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MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT03973567
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
In this study, diffusion tensor imaging(DTI)technique was used to evaluate the brain microstructures and connective white matter microstructures in patients with refractory FD, resting fMRI was used to evaluate the functional connectivity between hemispheres, and neuroimaging changes after antidepressant intervention were observed to explore the activation patterns of resting brain homeostasis-receptive network areas in patients with refractory FD. We aimed to explore microstructure of white matter and gray matter and functional connectivity between hemispheres to explain the therapeutic mechanism of antidepressants.

Condition or disease Intervention/treatment Phase
Therapeutic Mechanism of Antidepressants for Refractory FD Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants Other: conventional therapy Not Applicable

Detailed Description:
In this study, functional magnetic resonance imaging (fMRI) was used to investigate the abnormal activation patterns of brain regions in patients with refractory FD in resting state, and to observe the changes of brain functions after antidepressant treatment, in order to find scientific evidence for exploring the etiology, neuropathological mechanism and the mechanism of antidepressant treatment of refractory FD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: refractory FD patients using antidepressants
Sixty FD patients who met the criteria were selected as the experimental group after more than two kinds of treatment, including acid-making, proton pump inhibitors (PPI), motivation and anti-Helicobacter pylori(HP) treatment, including 30 in the conventional treatment group and 30 in the combined antidepressant treatment group.
Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants
On the basis of routine treatment for 8-12 weeks, according to the characteristics of symptoms, a combination of SSRI or SNRI antidepressant drugs was given for 12 weeks.

Placebo Comparator: refractory FD patienTS using conventional treatment
Sixty FD patients who met the criteria were selected as the experimental group after more than two kinds of treatment, including acid-making, PPI, motivation and anti-HP treatment, including 30 in the conventional treatment group and 30 in the combined antidepressant treatment group.
Other: conventional therapy
Anti-HP, acid suppression, gastrointestinal motility regulation, etc.

No Intervention: normal control
Age, sex and education matched, right-handed 30 normal people.



Primary Outcome Measures :
  1. Nepean Dyspepsia Index [ Time Frame: Change from Baseline at 12th week ]
    Evaluation of digestive tract symptoms


Secondary Outcome Measures :
  1. Zung Self-Rating Anxiety Scale [ Time Frame: Change from Baseline at 12th week ]
    It is a scale measures anxiety level of patients including 20 items, and total score ranges from 20 to 80. Higher values represent a worse outcome.

  2. Zung Self-Rating Depression Scale [ Time Frame: Change from Baseline at 12th week ]
    It is a scale measures depression level of patients including 20 items, and total score ranges from 20 to 80. Higher values represent a worse outcome.

  3. The Pittsburgh Sleep Quality Index [ Time Frame: Change from Baseline at 12th week ]
    Assessment of Sleep Status

  4. quality of life survey questionnaire [ Time Frame: Change from Baseline at 12th week ]
    Assessment of quality of life

  5. Incidence of Treatment-Emergent Adverse Events [ Time Frame: through study completion, an average of 3 years ]
    Record any adverse events during treatment

  6. Functional magnetic resonance imaging [ Time Frame: baseline and 12th week ]
    assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-60 years old, meeting the criteria for inclusion of refractory FD
  • HP infection negative
  • Right handedness

Exclusion Criteria:

  • Antidepressant drug allergists
  • History of gastroduodenal surgery;
  • Researchers judged suicidal ideation.
  • Women in pregnancy or lactation.
  • Patients with uncorrected narrow angle glaucoma.
  • There was a history of epileptic seizures.
  • suffering from any serious or unstable medical disease or disease.
  • Addiction to illicit drugs or alcohol and unwillingness to discontinue use during the study period.
  • Patients can't express their complaints correctly and can't cooperate with the researcher.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03973567


Contacts
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Contact: Yiping Chen, PHD 667117 rosechenaz@163.com
Contact: Rishen Yu, PHD 0571-87784817

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Yiping Chen, PHD    667117    rosechenaz@163.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Yiping Chen, PHD 2nd Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03973567     History of Changes
Other Study ID Numbers: 2016-042
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
antidepressants
refractory functional dyspepsia
resting fMRI
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Norepinephrine
Antidepressive Agents
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents