Therapeutic Mechanism of Antidepressants for Refractory FDNCT03973567
MRI Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
A study testing selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants and conventional therapy in people with Therapeutic Mechanism of Antidepressants for Refractory FD, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Mechanism of Antidepressants for Refractory FD
- What is being tested?
- selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants and conventional therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years old, meeting the criteria for inclusion of refractory FD
- HP infection negative
- Right handedness
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Rishen Yu, PHD contact
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Yiping Chen, PHD, 667117, rosechenaz@163.com
About this study
Official title: Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
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.
Read the 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.
- Being tested
- selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants, conventional therapy
- Keywords
- antidepressants, refractory functional dyspepsia, resting fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressantsDrug
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.
conventional therapyOther
Anti-HP, acid suppression, gastrointestinal motility regulation, etc.
| Study group | Role | What they receive |
|---|---|---|
| refractory FD patients using antidepressants | Experimental | 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. Receives: Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants |
| refractory FD patienTS using conventional treatment | Placebo comparator | 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. Receives: Other: conventional therapy |
| normal control | No intervention | Age, sex and education matched, right-handed 30 normal people. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nepean Dyspepsia Index
Evaluation of digestive tract symptoms
Measured: Change from Baseline at 12th week
Secondary outcomes (6)
Zung Self-Rating Anxiety Scale
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.
Measured: Change from Baseline at 12th week
Zung Self-Rating Depression Scale
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.
Measured: Change from Baseline at 12th week
The Pittsburgh Sleep Quality Index
Assessment of Sleep Status
Measured: Change from Baseline at 12th week
quality of life survey questionnaire
Assessment of quality of life
Measured: Change from Baseline at 12th week
Incidence of Treatment-Emergent Adverse Events
Record any adverse events during treatment
Measured: through study completion, an average of 3 years
Functional magnetic resonance imaging
assesses brain microstructures and connective white matter microstructures, and assesses functional connectivity between hemispheres
Measured: baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Mechanism of Antidepressants for Refractory FDStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiping Chen, PHD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973567
- Sponsor's protocol ID
- 2016-042
- Status last verified
- Jun 2019
- First submitted
- 28 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Study of Antidepressants in the Treatment of Refractory Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT03973567
- Acronym / sponsor ID
- 2016-042
- Keywords
- antidepressants, refractory functional dyspepsia, resting fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| refractory FD patients using antidepressants | Experimental | Drug: selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressantsSixty 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. |
| refractory FD patienTS using conventional treatment | Placebo comparator | Other: conventional therapySixty 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. |
| normal control | No intervention | –Age, sex and education matched, right-handed 30 normal people. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years old, meeting the criteria for inclusion of refractory FD
- HP infection negative
- Right handedness
Key exclusion criteria (9 listed)
- Antidepressant drug allergists
- History of gastroduodenal surgery;
- Researchers judged suicidal ideation.
- Women in pregnancy or lactation.
- Patients with uncorrected narrow angle glaucoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressantsOn 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. | Drug | refractory FD patients using antidepressants |
| conventional therapyAnti-HP, acid suppression, gastrointestinal motility regulation, etc. | Other | refractory FD patienTS using conventional treatment |
Primary outcome
Nepean Dyspepsia Index
Time frame: Change from Baseline at 12th week
Evaluation of digestive tract symptoms
6 secondary outcomes
Zung Self-Rating Anxiety Scale
Time frame: Change from Baseline at 12th week
Zung Self-Rating Depression Scale
Time frame: Change from Baseline at 12th week
The Pittsburgh Sleep Quality Index
Time frame: Change from Baseline at 12th week
quality of life survey questionnaire
Time frame: Change from Baseline at 12th week
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 3 years
Functional magnetic resonance imaging
Time frame: baseline and 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rishen Yu, PHD contact
Yiping Chen, PHD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants and conventional therapy in people with Therapeutic Mechanism of Antidepressants for Refractory FD, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiping Chen, PHD (667117, rosechenaz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nepean Dyspepsia Index (time frame: Change from Baseline at 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.