Major Depressive DisorderNCT07390981
Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder
A study testing Selective Serotonin Reuptake Inhibitors (SSRIs) and Intradermal Acupuncture in people with Major Depressive Disorder, run by First People's Hospital of Hangzhou.
Trial summary
This randomized controlled trial aims to evaluate the clinical efficacy of intradermal acupuncture as an adjunctive intervention to assist selective serotonin reuptake inhibitor (SSRI) dose reduction or discontinuation in adult patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Selective Serotonin Reuptake Inhibitors (SSRIs) and Intradermal Acupuncture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-60 years, irrespective of sex;
- A DSM-5 diagnosis of major depressive disorder, currently in full or partial remission, clinically stable for the preceding 3 months, and not meeting the criteria for a current major depressive episode;
- Continuous antidepressant treatment for at least 6 months, currently receiving a single SSRI, with the SSRI type and dose unchanged for at least 4 weeks before enrollment;
- Willing to taper the SSRI and deemed clinically suitable for gradual dose reduction by a psychiatrist;
- Provision of written informed consent.
Who cannot join
- Severe uncontrolled primary medical conditions
- Depression secondary to substances, medical illness, other psychiatric disorders (e.g., bipolar disorder, schizophrenia), or major bereavement
- Active suicidal ideation
- Pregnancy or lactation
- Cognitive impairment
- Bleeding disorders or allergy to adhesive materials
- Participation in another clinical trial within the past month
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
Official title: Clinical Efficacy and Effects on Autonomic Function of Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the clinical efficacy of intradermal acupuncture as an adjunctive intervention to assist selective serotonin reuptake inhibitor (SSRI) dose reduction or discontinuation in adult patients with major depressive disorder (MDD). Participants receiving SSRIs and planning gradual dose reduction or discontinuation will be randomly assigned to one of three groups: SSRI tapering alone, sham intradermal acupuncture plus SSRI tapering, or intradermal acupuncture plus SSRI tapering. Clinical outcomes and autonomic nervous system function will be assessed to determine the effectiveness and potential mechanisms of intradermal acupuncture in facilitating SSRI reduction and alleviating withdrawal-related symptoms.
- Conditions
- Major Depressive Disorder
- Being tested
- Selective Serotonin Reuptake Inhibitors (SSRIs), Sham Intradermal Acupuncture, Intradermal Acupuncture
- Keywords
- Intradermal Acupuncture, SSRIs, Heart Rate Variability
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Serotonin Reuptake Inhibitors (SSRIs)Drug
Participants will receive only standard oral SSRI antidepressant dose reduction, with dosage adjustments determined by a specialist physician, for a duration of 8 weeks.
Sham Intradermal AcupunctureProcedure or surgery
The sham intradermal needles are identical to the intradermal acupuncture needles in size, color, and material, with the needle body replaced by a thin silicone pad. The sham needles are applied to the selected acupoints and retained for 72 hours, followed by a 1-day rest period after removal. Acupoints: Shenmen (HT 7), Neiguan (PC 6), Sanyinjiao (SP 6), and Taichong (LR 3).
Intradermal AcupunctureProcedure or surgery
According to the location of the acupoints, intradermal acupuncture needles (φ0.20 × 1.5 mm or φ0.20 × 1.2 mm) are inserted vertically into the skin while avoiding blood vessels and retained for 72 hours, followed by a 1-day rest period after removal. During the retention period, participants are instructed to press the needles 3-4 times daily, with each stimulation lasting approximately 1 minute and an interval of 4 hours between sessions; the stimulation intensity is limited to the maximum level tolerated by the participant. Acupoints: Shenmen (HT 7), Neiguan (PC 6), Sanyinjiao (SP 6), and Taichong (LR 3).
| Study group | Role | What they receive |
|---|---|---|
| SSRI Tapering Group | Active comparator | Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks. Receives: Drug: Selective Serotonin Reuptake Inhibitors (SSRIs) |
| SSRI Tapering + Sham Intradermal Acupuncture | Sham comparator | Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks. Receives: Drug: Selective Serotonin Reuptake Inhibitors (SSRIs); Procedure: Sham Intradermal Acupuncture |
| SSRI Tapering + Intradermal Acupuncture | Experimental | Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks. Receives: Drug: Selective Serotonin Reuptake Inhibitors (SSRIs); Procedure: Intradermal Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
SSRI Dose Reduction Rate
Percentage reduction in SSRI dosage from baseline to each assessment point, calculated as:
(Baseline dose - Post-treatment dose) / Baseline dose × 100%
Measured: Week 4, Week 8 (end of treatment), Week 12 (follow-up)
Secondary outcomes (5)
Change in SSRI Dosage
Absolute change in SSRI dose from baseline.
Measured: Week 4, Week 8, Week 12
Depression Severity (HAMD-17)
Clinician-rated Hamilton Depression Rating Scale (17-item).
Measured: Baseline, Week 4, Week 8, Week 12
Depression Severity (SDS)
Self-Rating Depression Scale.
Measured: Baseline, Week 4, Week 8, Week 12
The Asberg Rating Scale for Side Effects (SERS)
The Asberg Rating Scale for Side Effects
Measured: Baseline, Week 4, Week 8, Week 12
Discontinuation-Emergent Signs and Symptoms (DESS)
Measured: Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingqi Tu, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390981
- Sponsor's protocol ID
- 2025KY394-1
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Effects on Autonomic Function of Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07390981
- Acronym / sponsor ID
- 2025KY394-1
- Conditions
- Major Depressive Disorder
- Keywords
- Intradermal Acupuncture, SSRIs, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Feb 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.
This randomized controlled trial aims to evaluate the clinical efficacy of intradermal acupuncture as an adjunctive intervention to assist selective serotonin reuptake inhibitor (SSRI) dose reduction or discontinuation in adult patients with major depressive disorder (MDD). Participants receiving SSRIs and planning gradual dose reduction or discontinuation will be randomly assigned to one of three groups: SSRI tapering alone, sham intradermal acupuncture plus SSRI tapering, or intradermal acupuncture plus SSRI tapering. Clinical outcomes and autonomic nervous system function will be assessed to determine the effectiveness and potential mechanisms of intradermal acupuncture in facilitating SSRI reduction and alleviating withdrawal-related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SSRI Tapering Group | Active comparator | Drug: Selective Serotonin Reuptake Inhibitors (SSRIs)Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks. |
| SSRI Tapering + Sham Intradermal Acupuncture | Sham comparator | Drug: Selective Serotonin Reuptake Inhibitors (SSRIs), Procedure: Sham Intradermal AcupunctureParticipants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks. |
| SSRI Tapering + Intradermal Acupuncture | Experimental | Drug: Selective Serotonin Reuptake Inhibitors (SSRIs), Procedure: Intradermal AcupunctureParticipants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-60 years, irrespective of sex;
- A DSM-5 diagnosis of major depressive disorder, currently in full or partial remission, clinically stable for the preceding 3 months, and not meeting the criteria for a current major depressive episode;
- Continuous antidepressant treatment for at least 6 months, currently receiving a single SSRI, with the SSRI type and dose unchanged for at least 4 weeks before enrollment;
- Willing to taper the SSRI and deemed clinically suitable for gradual dose reduction by a psychiatrist;
- Provision of written informed consent.
Key exclusion criteria (7 listed)
- Severe uncontrolled primary medical conditions
- Depression secondary to substances, medical illness, other psychiatric disorders (e.g., bipolar disorder, schizophrenia), or major bereavement
- Active suicidal ideation
- Pregnancy or lactation
- Cognitive impairment
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 |
|---|---|---|
| Selective Serotonin Reuptake Inhibitors (SSRIs)Participants will receive only standard oral SSRI antidepressant dose reduction, with dosage adjustments determined by a specialist physician, for a duration of 8 weeks. | Drug | SSRI Tapering + Intradermal Acupuncture, SSRI Tapering + Sham Intradermal Acupuncture, SSRI Tapering Group |
| Sham Intradermal AcupunctureThe sham intradermal needles are identical to the intradermal acupuncture needles in size, color, and material, with the needle body replaced by a thin silicone pad. The sham needles are applied to the selected acupoints and retained for 72 hours, followed by a 1-day rest period after removal. Acupoints: Shenmen (HT 7), Neiguan (PC 6), Sanyinjiao (SP 6), and Taichong (LR 3). | Procedure or surgery | SSRI Tapering + Sham Intradermal Acupuncture |
| Intradermal AcupunctureAccording to the location of the acupoints, intradermal acupuncture needles (φ0.20 × 1.5 mm or φ0.20 × 1.2 mm) are inserted vertically into the skin while avoiding blood vessels and retained for 72 hours, followed by a 1-day rest period after removal. During the retention period, participants are instructed to press the needles 3-4 times daily, with each stimulation lasting approximately 1 minute and an interval of 4 hours between sessions; the stimulation intensity is limited to the maximum level tolerated by the participant. Acupoints: Shenmen (HT 7), Neiguan (PC 6), Sanyinjiao (SP 6), and Taichong (LR 3). | Procedure or surgery | SSRI Tapering + Intradermal Acupuncture |
Primary outcome
SSRI Dose Reduction Rate
Time frame: Week 4, Week 8 (end of treatment), Week 12 (follow-up)
Percentage reduction in SSRI dosage from baseline to each assessment point, calculated as: (Baseline dose - Post-treatment dose) / Baseline dose × 100%
5 secondary outcomes
Change in SSRI Dosage
Time frame: Week 4, Week 8, Week 12
Depression Severity (HAMD-17)
Time frame: Baseline, Week 4, Week 8, Week 12
Depression Severity (SDS)
Time frame: Baseline, Week 4, Week 8, Week 12
The Asberg Rating Scale for Side Effects (SERS)
Time frame: Baseline, Week 4, Week 8, Week 12
Discontinuation-Emergent Signs and Symptoms (DESS)
Time frame: Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.
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 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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 study testing Selective Serotonin Reuptake Inhibitors (SSRIs) and Intradermal Acupuncture in people with Major Depressive Disorder, run by First People's Hospital of Hangzhou.
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 5 inclusion and 7 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 22 Sep 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.
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 Mingqi Tu (+86 15700067213, 403712321@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSRI Dose Reduction Rate (time frame: Week 4, Week 8 (end of treatment), Week 12 (follow-up)). 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 22 Sep 2026.