Hierarchical Treatment Based on Somatization Symptom Checklist

Phase 1

• Conditions: Syndrome X
• Interventions: Procedure: coronary artery disease treatment; Drug: Deanxit; Drug: Prozac

• Registration Number: NCT02723903
• Lead Sponsor: RenJi Hospital

Brief Summary

A comparative study is conducted on the patients with suspected coronary artery disease (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score and coronary angiography result. The efficacy, sensitivity and specificity of the SSS checklist will be evaluated during following up.

Detailed Description

The presentation of physical complaints such as chest discomfort suggestive of suspicious coronary artery disease (CAD) but remain unexplained after negative finding from coronary angiography represents one of the most frustrating and puzzling problems in clinical medicine.A comparative study is conducted on the patients with suspected coronary artery disease. A somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is treated according to the checklist score and coronary angiography result. Three surveys will be re-conducted 2 weeks after treatment. The sensitivity and specificity of the SSS checklist will be evaluated during following up.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-15
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients with suspected coronary artery disease

Exclusion Criteria

• patients who have lost their self assessments of capacity.
• patients who have been previously confirmed serious mental disorders.
• patients who is taking anti-anxiety agents or anti-depression agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with CAD, without somatic symptom	coronary artery disease treatment	Patient with the coronary artery disease, without the somatization symptom, the investigators treat the patients according to coronary artery disease treatment guideline including coronary artery stent implantation,medication according to the severity of stenosis of the coronary arteries.
with CAD and somatic symptom	coronary artery disease treatment	Patients with the coronary artery disease and with the somatization symptom, the investigators treat the patients according to the guideline for coronary artery disease and anti-somatic agents (Deanxit, Prozac according to the somatization type)
with CAD and somatic symptom	Deanxit	Patients with the coronary artery disease and with the somatization symptom, the investigators treat the patients according to the guideline for coronary artery disease and anti-somatic agents (Deanxit, Prozac according to the somatization type)
with CAD and somatic symptom	Prozac	Patients with the coronary artery disease and with the somatization symptom, the investigators treat the patients according to the guideline for coronary artery disease and anti-somatic agents (Deanxit, Prozac according to the somatization type)
without CAD, with somatic symptom	Deanxit	Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)
without CAD, with somatic symptom	Prozac	Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)

Primary Outcome Measures

Name	Time	Method
The efficacy of somatization symptom score	2 weeks after the first visit	observe the efficacy by the score of somatic symptom scale (SSS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-items (GAD-7)

Secondary Outcome Measures

Name	Time	Method
The efficacy of Patient Health Questionnaire	2 weeks after the first visit	observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)
scale chest discomfort	2 weeks after the first visit	observe if the chest discomfort no change, alleviate or disappear
The efficacy of Generalized Anxiety Disorder 7-items	2 weeks after the first visit	observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China