Post-stroke DepressionPhase 4NCT07739329
A Study on the Preventive Effect of Electroacupuncture Combined With Dexmedetomidine in Post-stroke Depression
A Phase 4 study testing Dexmedetomidine, Electropuncture and Normal Saline (NS) in people with Post-stroke Depression, run by Min Su.
Trial summary
Post-stroke depression (PSD) is a common neuropsychiatric complication following stroke and has emerged as a major public health concern due to its adverse impact on post-stroke prognosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Dexmedetomidine, Electropuncture and Normal Saline (NS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ischemic stroke with a disease course of less than 2 weeks;
- Patients with high-risk PSD;
- The patient can accept the treatment plan described in this trial and sign the informed consent form.
Who cannot join
- Cognitive impairment;
- Severe aphasia or significant language impairment;
- Disturbance of consciousness;
- History of psychiatric disorders, including but not limited to depression, schizophrenia, and bipolar disorder;
- Alcohol or substance dependence;
- Use of sedatives or antipsychotic medications within 2 weeks prior to screening;
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- Severe cardiac, hepatic, or renal dysfunction;
- Complicated with acute severe conditions or unstable vital signs;
- Pregnancy or lactation;
- Contraindications or intolerance to electroacupuncture;
- Sick sinus syndrome, severe bradycardia (heart rate < 50 bpm), second-degree or higher atrioventricular block, permanent pacemaker implantation, severe heart failure, or ejection fraction < 30%;
- Known allergy to any of the study medications;
- Inability to complete the study procedures due to any unavoidable circumstances.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Post-stroke depression (PSD) is a common neuropsychiatric complication following stroke and has emerged as a major public health concern due to its adverse impact on post-stroke prognosis. Clinical studies have confirmed that early intervention with electroacupuncture can significantly reduce PSD incidence and alleviate depressive severity. Mechanistically, electroacupuncture exerts antidepressant effects through inhibition of the endoplasmic reticulum stress pathway and attenuation of neuronal apoptosis. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, not only provides sedation and analgesia but also confers neuroprotective actions, including anti-inflammatory, anti-apoptotic, and blood-brain barrier protective effects. Its efficacy in preventing postpartum depression has been clinically validated. Given the substantial burden of PSD and the limitations of existing preventive approaches, the present study aims to investigate the value of a combined electroacupuncture and dexmedetomidine strategy for PSD prevention, with the goal of developing a safe and effective integrative treatment regimen for this frequent post-stroke complication.
- Conditions
- Post-stroke Depression
- Being tested
- Dexmedetomidine, Electropuncture, Normal Saline (NS), Shame electropuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Intranasal titration of dexmedetomidine (1μg/kg)
ElectropunctureDrug
Electroacupuncture treatment
Normal Saline (NS)Drug
0.9% normal saline
Shame electropunctureDrug
Shame electropuncture treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group was given an equal dose of normal saline and sham electroacupuncture treatment. Receives: Drug: Normal Saline (NS); Drug: Shame electropuncture |
| Electroacupuncture group | Active comparator | The electroacupuncture group was given an equal dose of normal saline and received electroacupuncture treatment. Receives: Drug: Electropuncture; Drug: Normal Saline (NS) |
| The electroacupuncture combined with dexmedetomidine group | Active comparator | The electroacupuncture combined with dexmedetomidine group was given intranasal titration of dexmedetomidine (original form, 1 μg/kg), and was treated with electroacupuncture simultaneously. Receives: Drug: Dexmedetomidine; Drug: Electropuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PSD 3 months after stroke
Measured: 3 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739329
- Sponsor's protocol ID
- 2026ECD07
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Preventive Effect of Electroacupuncture Combined With Dexmedetomidine in Post-stroke Depression
- ClinicalTrials.gov ID
- NCT07739329
- Acronym / sponsor ID
- 2026ECD07
- Conditions
- Post-stroke Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 2026 (actual)
- 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.
Post-stroke depression (PSD) is a common neuropsychiatric complication following stroke and has emerged as a major public health concern due to its adverse impact on post-stroke prognosis. Clinical studies have confirmed that early intervention with electroacupuncture can significantly reduce PSD incidence and alleviate depressive severity. Mechanistically, electroacupuncture exerts antidepressant effects through inhibition of the endoplasmic reticulum stress pathway and attenuation of neuronal apoptosis. Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, not only provides sedation and analgesia but also confers neuroprotective actions, including anti-inflammatory, anti-apoptotic, and blood-brain barrier protective effects. Its efficacy in preventing postpartum depression has been clinically validated. Given the substantial burden of PSD and the limitations of existing preventive approaches, the present study aims to investigate the value of a combined electroacupuncture and dexmedetomidine strategy for PSD prevention, with the goal of developing a safe and effective integrative treatment regimen for this frequent post-stroke complication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Normal Saline (NS), Drug: Shame electropunctureThe control group was given an equal dose of normal saline and sham electroacupuncture treatment. |
| Electroacupuncture group | Active comparator | Drug: Electropuncture, Drug: Normal Saline (NS)The electroacupuncture group was given an equal dose of normal saline and received electroacupuncture treatment. |
| The electroacupuncture combined with dexmedetomidine group | Active comparator | Drug: Dexmedetomidine, Drug: ElectropunctureThe electroacupuncture combined with dexmedetomidine group was given intranasal titration of dexmedetomidine (original form, 1 μg/kg), and was treated with electroacupuncture simultaneously. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic stroke with a disease course of less than 2 weeks;
- Patients with high-risk PSD;
- The patient can accept the treatment plan described in this trial and sign the informed consent form.
Key exclusion criteria (13 listed)
- Cognitive impairment;
- Severe aphasia or significant language impairment;
- Disturbance of consciousness;
- History of psychiatric disorders, including but not limited to depression, schizophrenia, and bipolar disorder;
- Alcohol or substance dependence;
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 |
|---|---|---|
| DexmedetomidineIntranasal titration of dexmedetomidine (1μg/kg) | Drug | The electroacupuncture combined with dexmedetomidine group |
| ElectropunctureElectroacupuncture treatment | Drug | Electroacupuncture group, The electroacupuncture combined with dexmedetomidine group |
| Normal Saline (NS)0.9% normal saline | Drug | Control group, Electroacupuncture group |
| Shame electropunctureShame electropuncture treatment | Drug | Control group |
Primary outcome
The incidence of PSD 3 months after stroke
Time frame: 3 months after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Electropuncture and Normal Saline (NS) in people with Post-stroke Depression, run by Min Su.
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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanping Zhang (+8615223049366, zhangyp8415@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of PSD 3 months after stroke (time frame: 3 months after stroke). 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 31 Jul 2026.