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

NCT07115472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-08-14

No results posted yet for this study

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)

Interventions

DRUG

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.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-01
Completion
2025-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115472 on ClinicalTrials.gov