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Tests treatment safety and results for Depressive Disorder (Per DSM-V Criteria,...
Official title Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study
ClinicalTrials.gov ID: NCT07454070
What this study is testing
- What it's testing
- This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Meeting the diagnostic criteria for ACS
- 14 days to 12 months after successful PCI, with stable vital signs
- Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- HAMD-17 score ≥7 and \<24 (mild-to-moderate depression), with HAMA score \<HAMD score;
You likely can't join if
- Severe heart failure (New York Heart Association [NYHA] class ≥III)
- Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg)
- Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree...
- Dialysis-dependent patients
- Previous renal sympathetic denervation or vagal ganglion ablation
- Expected survival time \<4 months
See the full eligibility criteria
- Age ≥18 years
- Meeting the diagnostic criteria for ACS
- 14 days to 12 months after successful PCI, with stable vital signs
- Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
- HAMD-17 score ≥7 and \<24 (mild-to-moderate depression), with HAMA score \<HAMD score;
- Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent
- Voluntary participation in the study and signing of the informed consent form
- Severe heart failure (New York Heart Association [NYHA] class ≥III)
- Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg)
- Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per...
- Dialysis-dependent patients
- Previous renal sympathetic denervation or vagal ganglion ablation
- Expected survival time \<4 months
- Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse
- Current use of antipsychotic medications
- High suicide risk
- Pregnant or lactating women
- Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment
- Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.