NCT07390981

Intradermal Acupuncture for Assisting SSRI Dose Reduction in Major Depressive Disorder

Clinical Efficacy of Intradermal Acupuncture as an Adjunct to SSRI Dose Reduction or Discontinuation in Patients With Major Depressive Disorder and Its Mechanisms of Autonomic Nervous System Regulation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	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.
PROCEDURE	Sham Intradermal Acupuncture	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).
PROCEDURE	Intradermal Acupuncture	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).

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-10-31
• Completion: 2028-12-31
• First posted: 2026-02-05
• Last updated: 2026-03-25