Fluoxetine in Refractory Superior Mesenteric Artery Syndrome by Targeting Comorbid Somatic Symptom Disorder

NCT07115472 | Completed

• 1 other identifier: KY20242188
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Superior Mesenteric Artery Syndrome; Somatic Symptom Disorder (DSM-5)

Keywords

Fluoxetine

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after treatment initiation

Study Arms (1)

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.

Drug: Fluoxetine

Interventions

Fluoxetine DRUG

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.

Fluoxetine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Superior Mesenteric Artery Syndrome

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Duodenal Obstruction; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: For more information or to submit a request, please contact zhaozhifeng@outlook.com.

Locations

CN (1)