Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder

NCT07390981 — Not applicable, Not yet recruiting, 114 participants, First People's Hospital of Hangzhou

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Clinical Efficacy and Effects on Autonomic Function of Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder: A Randomized Controlled Trial

Registry	NCT07390981
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	114 (Estimated)
Sponsor	First People's Hospital of Hangzhou (Other)
Conditions	Major Depressive Disorder
Interventions	Selective Serotonin Reuptake Inhibitors (SSRIs), Sham Intradermal Acupuncture, Intradermal Acupuncture (Drug, procedure)
Dates	start 2026-10-01 (estimated), primary completion 2028-10-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-02-05, last updated 2026-09-22

-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). 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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 Acupuncture	Participants 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 Acupuncture	Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.

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 Acupuncture (Procedure): 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 Acupuncture (Procedure): 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).

+Outcome measures

Primary outcomes

SSRI Dose Reduction Rate [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%

Secondary outcomes

Change in SSRI Dosage [Week 4, Week 8, Week 12]: Absolute change in SSRI dose from baseline.
Depression Severity (HAMD-17) [Baseline, Week 4, Week 8, Week 12]: Clinician-rated Hamilton Depression Rating Scale (17-item).
Depression Severity (SDS) [Baseline, Week 4, Week 8, Week 12]: Self-Rating Depression Scale.
The Asberg Rating Scale for Side Effects (SERS) [Baseline, Week 4, Week 8, Week 12]: The Asberg Rating Scale for Side Effects
Discontinuation-Emergent Signs and Symptoms (DESS) [Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.]

Other outcomes

Autonomic Nervous System Function (HRV Parameters) [Baseline, Week 8]: Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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