Hierarchical Treatment Based on Somatization Symptom Checklist

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Syndrome X

Treatments: Drug: Prozac; Procedure: coronary artery disease treatment; Drug: Deanxit

Study type: Interventional

Funder types: Other

Identifiers

NCT02723903

81470391

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

with CAD and somatic symptom

Other group

Description:

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)

Treatment:

Drug: Deanxit

Procedure: coronary artery disease treatment

Drug: Prozac

without CAD, with somatic symptom

Other group

Description:

Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)

Treatment:

Drug: Deanxit

Drug: Prozac

without CAD, without somatic symptom

No Intervention group

Description:

Have neither coronary artery disease nor somatic symptom, continue follow-up.

with CAD, without somatic symptom

Other group

Description:

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.

Treatment:

Procedure: coronary artery disease treatment