Syndrome XPhase 1/2NCT02723903
Hierarchical Treatment Based on Somatization Symptom Checklist
A Phase 1/2 study testing Deanxit, Prozac and coronary artery disease treatment in people with Syndrome X, run by RenJi Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Syndrome X
- What is being tested?
- Deanxit, Prozac and coronary artery disease treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with suspected coronary artery disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai
Wang lingling, Postgraduate, 15000053961
Chen bingxu, Postgraduate, 15800539513
About this study
Official title: Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography
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.
- Conditions
- Syndrome X
- Being tested
- Deanxit, Prozac, coronary artery disease treatment
- Keywords
- somatization symptom score, SSS checklist, coronary angiography, Patient Health Questionnaire, Generalized Anxiety Disorder 7-items
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeanxitDrug
Also called Deanxit as anti-anxiety treatment
we use Deanxit for the patient with anxiety
ProzacDrug
Also called Prozac as anti-depression treatment
we use Prozac for the patient with depression
coronary artery disease treatmentProcedure or surgery
Also called re-vascularization
including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| with CAD and somatic symptom | Other | 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) Receives: Drug: Deanxit; Drug: Prozac; Procedure: coronary artery disease treatment |
| without CAD, with somatic symptom | Other | Only somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type) Receives: Drug: Deanxit; Drug: Prozac |
| without CAD, without somatic symptom | No intervention | Have neither coronary artery disease nor somatic symptom, continue follow-up. |
| with CAD, without somatic symptom | Other | 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. Receives: Procedure: coronary artery disease treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks after the first visit
Secondary outcomes (3)
scale chest discomfort
observe if the chest discomfort no change, alleviate or disappear
Measured: 2 weeks after the first visit
The efficacy of Patient Health Questionnaire
observe the efficacy by the score of Patient Health Questionnaire (PHQ-9)
Measured: 2 weeks after the first visit
The efficacy of Generalized Anxiety Disorder 7-items
observe the efficacy by the score of Generalized Anxiety Disorder 7-items (GAD-7)
Measured: 2 weeks after the first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mao Jialiang, Docter, Study chair, Renji hosipital,Jiaotong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723903
- Sponsor's protocol ID
- 81470391
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography
- ClinicalTrials.gov ID
- NCT02723903
- Acronym / sponsor ID
- 81470391
- Conditions
- Syndrome X
- Keywords
- somatization symptom score, SSS checklist, coronary angiography, Patient Health Questionnaire, Generalized Anxiety Disorder 7-items
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| with CAD and somatic symptom | Other | Drug: Deanxit, Drug: Prozac, Procedure: coronary artery disease treatmentPatients 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 | Other | Drug: Deanxit, Drug: ProzacOnly somatic symptom is presented, anti-somatic agents is prescribed (Deanxit, Prozac according to the somatization type) |
| without CAD, without somatic symptom | No intervention | –Have neither coronary artery disease nor somatic symptom, continue follow-up. |
| with CAD, without somatic symptom | Other | Procedure: coronary artery disease treatmentPatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with suspected coronary artery disease
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeanxitAlso: Deanxit as anti-anxiety treatmentwe use Deanxit for the patient with anxiety | Drug | with CAD and somatic symptom, without CAD, with somatic symptom |
| ProzacAlso: Prozac as anti-depression treatmentwe use Prozac for the patient with depression | Drug | with CAD and somatic symptom, without CAD, with somatic symptom |
| coronary artery disease treatmentAlso: re-vascularizationincluding medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries | Procedure or surgery | with CAD and somatic symptom, with CAD, without somatic symptom |
Primary outcome
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)
3 secondary outcomes
scale chest discomfort
Time frame: 2 weeks after the first visit
The efficacy of Patient Health Questionnaire
Time frame: 2 weeks after the first visit
The efficacy of Generalized Anxiety Disorder 7-items
Time frame: 2 weeks after the first visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mao Jialiang, Docter study chair
Renji hosipital,Jiaotong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deanxit, Prozac and coronary artery disease treatment in people with Syndrome X, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mao Jialiang, Docter (13311606283 ext. 68383477, maoji@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of somatization symptom score (time frame: 2 weeks after the first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.