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Status unknownNCT02723903Updated Mar 4, 2020

Hierarchical Treatment Based on Somatization Symptom Checklist

A Phase 1/2 interventional study of Deanxit and Prozac in Syndrome X, sponsored by RenJi Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by RenJi Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Syndrome X

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Keywords

  • somatization symptom score
  • SSS checklist
  • coronary angiography
  • Patient Health Questionnaire
  • Generalized Anxiety Disorder 7-items
03

In context

Microvascular Angina

126 studies on the registry are indexed under Microvascular Angina; 37 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 80 interventional studies indexed under Microvascular Angina.

Browse Microvascular Angina studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 248 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with suspected coronary artery disease

Exclusion criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    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 · Drug: Prozac · Procedure: coronary artery disease treatment

  • Other
    without CAD, with somatic symptom

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

    Drug: Deanxit · Drug: Prozac

  • No intervention
    without CAD, without somatic symptom

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

  • Other
    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

Interventions

  • DrugDeanxit

    we use Deanxit for the patient with anxiety

    Also known as: Deanxit as anti-anxiety treatment

  • DrugProzac

    we use Prozac for the patient with depression

    Also known as: Prozac as anti-depression treatment

  • Procedurecoronary artery disease treatment

    including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries

    Also known as: re-vascularization

06

What researchers measure

Primary outcomes

  1. The efficacy of somatization symptom score

    observe the efficacy by the score of somatic symptom scale (SSS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder 7-items (GAD-7)

    Time frame: 2 weeks after the first visit

Secondary outcomes

  1. scale chest discomfort

    observe if the chest discomfort no change, alleviate or disappear

    Time frame: 2 weeks after the first visit

  2. The efficacy of Patient Health Questionnaire

    observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)

    Time frame: 2 weeks after the first visit

  3. The efficacy of Generalized Anxiety Disorder 7-items

    observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)

    Time frame: 2 weeks after the first visit

07

Study locations

1 of 1 sites recruiting
  • Renji Hospital
    Shanghai, China
    • Wang lingling, Postgraduate · Contact · 15000053961
    • Chen bingxu, Postgraduate · Contact · 15800539513
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of Dec 2020 and a completion of Dec 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2016
First posted
Mar 31, 2016
Start
Dec 2015
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2021
Last update
Mar 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02723903
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Mar 31, 2016
Start date
Dec 2015
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Mar 4, 2020

Study contacts

Mao Jialiang, Docter
Contact
maoji@aliyun.com
13311606283 ext. 68383477
Jiang Meng, Doctor
Contact
jiangmeng0919@163.com
13788912766 ext. 58752445
Mao Jialiang, Docter
study chair · Renji hosipital,Jiaotong University, School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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