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

Not Applicable

Completed

• Conditions: Superior Mesenteric Artery Syndrome; Somatic Symptom Disorder (DSM-5)
• Interventions: Drug: Fluoxetine

• Registration Number: NCT07115472
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-08-03
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. 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;
2. refractory SMAS was defined as failure of conservative treatments, including gastrointestinal decompression, enteral nutrition and parenteral nutrition;
3. 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;
4. meets the aforementioned criteria for SSD;
5. voluntarily provided informed consent prior to enrollment.

Exclusion Criteria

1. secondary SMAS due to identifiable causes such as tuberculosis or liver cirrhosis;
2. pregnant or lactating women;
3. patients with malignant tumors or autoimmune diseases;
4. individuals with cardiovascular diseases, organ failure, cognitive impairments, aphasia, or other chronic conditions which interfere with examinations and treatment;
5. psychotropic agents' allergic patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluoxetine	Fluoxetine	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 Outcome Measures

Name	Time	Method
Proportion of patients achieving GOOSS ≥ 2 at 6 months	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China