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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Superior Mesenteric Artery Syndrome Digestive System Diseases Duodenal Diseases Duodenal Obstruction Gastrointestinal Diseases Intestinal Diseases Somatic Symptom Disorder (DSM-5)

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

Fluoxetine as a Non-Surgical Intervention for Refractory Superior Mesenteric Artery Syndrome With Comorbid Somatic Symptom Disorder: A Prospective Case Series Study

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Aug 11, 2025
Registry last updated: Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed