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Hierarchical Treatment Based on Somatization Symptom Checklist

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ClinicalTrials.gov Identifier: NCT02723903
Recruitment Status : Unknown
Verified March 2016 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Syndrome X Drug: Deanxit Drug: Prozac Procedure: coronary artery disease treatment Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
with CAD and somatic symptom
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)
Drug: Deanxit
we use Deanxit for the patient with anxiety
Other Name: Deanxit as anti-anxiety treatment

Drug: Prozac
we use Prozac for the patient with depression
Other Name: Prozac as anti-depression treatment

Procedure: coronary artery disease treatment
including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries
Other Name: re-vascularization

without CAD, with somatic symptom
Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type)
Drug: Deanxit
we use Deanxit for the patient with anxiety
Other Name: Deanxit as anti-anxiety treatment

Drug: Prozac
we use Prozac for the patient with depression
Other Name: Prozac as anti-depression treatment

No Intervention: without CAD, without somatic symptom
Have neither coronary artery disease nor somatic symptom, continue follow-up.
with CAD, without somatic symptom
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.
Procedure: coronary artery disease treatment
including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries
Other Name: re-vascularization




Primary Outcome Measures :
  1. The efficacy of somatization symptom score [ Time Frame: 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 :
  1. scale chest discomfort [ Time Frame: 2 weeks after the first visit ]
    observe if the chest discomfort no change, alleviate or disappear

  2. The efficacy of Patient Health Questionnaire [ Time Frame: 2 weeks after the first visit ]
    observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)

  3. The efficacy of Generalized Anxiety Disorder 7-items [ Time Frame: 2 weeks after the first visit ]
    observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723903


Contacts
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Contact: Mao Jialiang, Docter 13311606283 ext 68383477 maoji@aliyun.com
Contact: Jiang Meng, Doctor 13788912766 ext 58752445 jiangmeng0919@163.com

Locations
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China
Renji Hospital Recruiting
Shanghai, China
Contact: Wang lingling, Postgraduate    15000053961      
Contact: Chen bingxu, Postgraduate    15800539513      
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Mao Jialiang, Docter Renji hosipital,Jiaotong University, School of Medicine

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02723903     History of Changes
Other Study ID Numbers: 81470391
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by RenJi Hospital:
somatization symptom score
SSS checklist
coronary angiography
Patient Health Questionnaire
Generalized Anxiety Disorder 7-items

Additional relevant MeSH terms:
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Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors