Superior Mesenteric Artery SyndromeNCT07115472
Fluoxetine in Refractory Superior Mesenteric Artery Syndrome by Targeting Comorbid Somatic Symptom Disorder
A study testing Fluoxetine in people with Superior Mesenteric Artery Syndrome and Somatic Symptom Disorder (DSM-5), run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The goal of this interventional study is to evaluate whether fluoxetine, a selective serotonin reuptake inhibitor (SSRI), can alleviate core symptoms and reduce the need for surgical intervention in patients with refractory superior mesenteric artery syndrome (SMAS) who meet diagnostic criteria for somatic symptom… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superior Mesenteric Artery Syndrome, Somatic Symptom Disorder (DSM-5)
- What is being tested?
- Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- SMAS was confirmed by two key indicators using imaging or angiographic criteria: aortomesenteric angle of less than 22° or aortomesenteric distance of less than 8 mm;
- refractory SMAS was defined as failure of conservative treatments, including gastrointestinal decompression, enteral nutrition and parenteral nutrition;
- accompanied by one or more following characteristics: Severe upper gastrointestinal symptoms (nausea, vomiting, bloating, pain), usually occurring more than once a week; body mass index (BMI)<18.5 kg/m2 related to feeding difficulties;
- meets the aforementioned criteria for SSD;
- voluntarily provided informed consent prior to enrollment.
Who cannot join
- secondary SMAS due to identifiable causes such as tuberculosis or liver cirrhosis;
- pregnant or lactating women;
- patients with malignant tumors or autoimmune diseases;
- individuals with cardiovascular diseases, organ failure, cognitive impairments, aphasia, or other chronic conditions which interfere with examinations and treatment;
- psychotropic agents' allergic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoxetine as a Non-Surgical Intervention for Refractory Superior Mesenteric Artery Syndrome With Comorbid Somatic Symptom Disorder: A Prospective Case Series Study
The goal of this interventional study is to evaluate whether fluoxetine, a selective serotonin reuptake inhibitor (SSRI), can alleviate core symptoms and reduce the need for surgical intervention in patients with refractory superior mesenteric artery syndrome (SMAS) who meet diagnostic criteria for somatic symptom disorder (SSD). The main questions it aims to answer are:
Can fluoxetine improve abdominal symptoms and nutritional status in patients with SMAS and comorbid SSD?
Read more
Can psychiatric intervention targeting SSD reduce the likelihood of requiring duodenojejunostomy in refractory SMAS?
Participants will:
Receive oral fluoxetine therapy for a planned treatment duration of 6 months.
Undergo baseline and follow-up assessments including symptom scoring (pain, nausea, dietary intake), body weight/BMI monitoring, and psychiatric evaluation.
Complete psychological questionnaires (PHQ-15, GAD-7, PHQ-9) and resting-state fMRI at baseline and study endpoint.
- Being tested
- Fluoxetine
- Keywords
- Fluoxetine
- Medical subject headings
- Superior Mesenteric Artery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Refractory SMAS patients with SSD received oral fluoxetine treatment, initiated at 20 mg/day and increased to a maximum of 60 mg/day based on therapeutic response.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine | Experimental | Refractory SMAS patients with SSD received oral fluoxetine treatment, initiated at 20 mg/day and increased to a maximum of 60 mg/day based on therapeutic response. Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving GOOSS ≥ 2 at 6 months
Treatment efficacy was evaluated using the Gastric Outlet Obstruction Scoring System (GOOSS), a validated 4-point scale assessing the patient's ability to tolerate oral intake: 0 = no oral intake, 1 = liquids only, 2 = semi-solids, and 3 = low-residue or full diet. The primary efficacy endpoint was the proportion of patients achieving a GOOSS score ≥ 2 at 6 months, indicating the ability to tolerate at least a semi-solid diet.
Measured: 6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Mesenteric Artery SyndromeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Zhao, PhD, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115472
- Sponsor's protocol ID
- KY20242188
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoxetine as a Non-Surgical Intervention for Refractory Superior Mesenteric Artery Syndrome With Comorbid Somatic Symptom Disorder: A Prospective Case Series Study
- ClinicalTrials.gov ID
- NCT07115472
- Acronym / sponsor ID
- KY20242188
- Keywords
- Fluoxetine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 11 Aug 2025 (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.
The goal of this interventional study is to evaluate whether fluoxetine, a selective serotonin reuptake inhibitor (SSRI), can alleviate core symptoms and reduce the need for surgical intervention in patients with refractory superior mesenteric artery syndrome (SMAS) who meet diagnostic criteria for somatic symptom disorder (SSD). The main questions it aims to answer are:
Can fluoxetine improve abdominal symptoms and nutritional status in patients with SMAS and comorbid SSD?
Can psychiatric intervention targeting SSD reduce the likelihood of requiring duodenojejunostomy in refractory SMAS?
Participants will:
Receive oral fluoxetine therapy for a planned treatment duration of 6 months.
Undergo baseline and follow-up assessments including symptom scoring (pain, nausea, dietary intake), body weight/BMI monitoring, and psychiatric evaluation.
Complete psychological questionnaires (PHQ-15, GAD-7, PHQ-9) and resting-state fMRI at baseline and study endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine | Experimental | Drug: FluoxetineRefractory SMAS patients with SSD received oral fluoxetine treatment, initiated at 20 mg/day and increased to a maximum of 60 mg/day based on therapeutic response. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- SMAS was confirmed by two key indicators using imaging or angiographic criteria: aortomesenteric angle of less than 22° or aortomesenteric distance of less than 8 mm;
- refractory SMAS was defined as failure of conservative treatments, including gastrointestinal decompression, enteral nutrition and parenteral nutrition;
- accompanied by one or more following characteristics: Severe upper gastrointestinal symptoms (nausea, vomiting, bloating, pain), usually occurring more than once a week; body mass index (BMI)<18.5 kg/m2 related to feeding difficulties;
- meets the aforementioned criteria for SSD;
- voluntarily provided informed consent prior to enrollment.
Key exclusion criteria (5 listed)
- secondary SMAS due to identifiable causes such as tuberculosis or liver cirrhosis;
- pregnant or lactating women;
- patients with malignant tumors or autoimmune diseases;
- individuals with cardiovascular diseases, organ failure, cognitive impairments, aphasia, or other chronic conditions which interfere with examinations and treatment;
- psychotropic agents' allergic patients.
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 |
|---|---|---|
| FluoxetineRefractory SMAS patients with SSD received oral fluoxetine treatment, initiated at 20 mg/day and increased to a maximum of 60 mg/day based on therapeutic response. | Drug | Fluoxetine |
Primary outcome
Proportion of patients achieving GOOSS ≥ 2 at 6 months
Time frame: 6 months after treatment initiation
Treatment efficacy was evaluated using the Gastric Outlet Obstruction Scoring System (GOOSS), a validated 4-point scale assessing the patient's ability to tolerate oral intake: 0 = no oral intake, 1 = liquids only, 2 = semi-solids, and 3 = low-residue or full diet. The primary efficacy endpoint was the proportion of patients achieving a GOOSS score ≥ 2 at 6 months, indicating the ability to tolerate at least a semi-solid diet.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Yes. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine in people with Superior Mesenteric Artery Syndrome and Somatic Symptom Disorder (DSM-5), run by Xijing Hospital of Digestive Diseases 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving GOOSS ≥ 2 at 6 months (time frame: 6 months after treatment initiation). 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 14 Aug 2025.