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

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 Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Selective Serotonin Reuptake Inhibitors (SSRIs); Procedure: Sham Intradermal Acupuncture; Procedure: Intradermal Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingqi Tu; Phone Number: +86 15700067213; Email: 403712321@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-60 years

Diagnosis of major depressive disorder according to DSM-5

Currently receiving SSRI treatment and planning gradual dose reduction or discontinuation

Clear consciousness and ability to communicate normally

Willingness to participate and provide 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SSRI Tapering Group; Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks.	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.
Sham Comparator: SSRI Tapering + Sham Intradermal Acupuncture; Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.	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).
Experimental: SSRI Tapering + Intradermal Acupuncture; Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.	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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	Week 4, Week 8 (end of treatment), Week 12 (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SSRI Dosage	Absolute change in SSRI dose from baseline.	Week 4, Week 8, Week 12
Depression Severity (HAMD-17)	Clinician-rated Hamilton Depression Rating Scale (17-item).	Baseline, Week 4, Week 8, Week 12
Depression Severity (SDS)	Self-Rating Depression Scale.	Baseline, Week 4, Week 8, Week 12
Autonomic Nervous System Function (HRV Parameters)	Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring.	Baseline, Week 8
The Asberg Rating Scale for Side Effects (SERS)	The Asberg Rating Scale for Side Effects	Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Heart Rate Variability; SSRIs; Intradermal Acupuncture
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Neurotransmitter Uptake Inhibitors; Serotonin Agents; Pharmacologic Actions; Chemical Actions and Uses; Selective Serotonin Reuptake Inhibitors
• Other Study ID Numbers: 2025KY394-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No