Intradermal Acupuncture for Assisting SSRI Dose Reduction in Major Depressive Disorder

NCT07390981 | Not Yet Recruiting DMC

• 1 other identifier: 2025KY394-1
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Intradermal Acupuncture; SSRIs; Heart Rate Variability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in SSRI Dosage

  Week 4, Week 8, Week 12

• Depression Severity (HAMD-17)

  Baseline, Week 4, Week 8, Week 12

• Depression Severity (SDS)

  Baseline, Week 4, Week 8, Week 12

• The Asberg Rating Scale for Side Effects (SERS)

  Baseline, Week 4, Week 8, Week 12

• Autonomic Nervous System Function (HRV Parameters)

  Baseline, Week 8

Study Arms (3)

SSRI Tapering Group

ACTIVE COMPARATOR

Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks.

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.

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.

Drug: Selective Serotonin Reuptake Inhibitors (SSRIs); Procedure: Intradermal Acupuncture

Interventions

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.

SSRI Tapering + Intradermal Acupuncture; SSRI Tapering + Sham Intradermal Acupuncture; SSRI Tapering Group

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).

SSRI Tapering + Sham Intradermal Acupuncture

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).

SSRI Tapering + Intradermal Acupuncture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Central Study Contacts

Mingqi Tu

CONTACT

+86 15700067213; 403712321@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Philosophy

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share