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

Xijing Hospital of Digestive Diseases

Status: Completed

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

Treatments: Drug: Fluoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT07115472

KY20242188

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Fluoxetine

Experimental group

Description:

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.

Treatment:

Drug: Fluoxetine