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Clinical Trials/NCT07390981
NCT07390981Not yet recruitingNot Applicable

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

First People's Hospital of Hangzhou0 sites114 target enrollmentStarted: March 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
114
Primary Endpoint
SSRI Dose Reduction Rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

SSRI Tapering Group

Active Comparator

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

Intervention: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)

SSRI Tapering + Sham Intradermal Acupuncture

Sham Comparator

Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.

Intervention: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)

SSRI Tapering + Sham Intradermal Acupuncture

Sham Comparator

Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.

Intervention: Sham Intradermal Acupuncture (Procedure)

SSRI Tapering + Intradermal Acupuncture

Experimental

Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.

Intervention: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)

SSRI Tapering + Intradermal Acupuncture

Experimental

Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.

Intervention: Intradermal Acupuncture (Procedure)

Outcomes

Primary Outcomes

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%

Secondary Outcomes

  • 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)
  • Antidepressant-Related Adverse Effects (SERS)(Baseline, Week 4, Week 8, Week 12)
  • Autonomic Nervous System Function (HRV Parameters)(Baseline, Week 8)

Investigators

Sponsor
First People's Hospital of Hangzhou
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mingqi Tu

Doctor of Philosophy

First People's Hospital of Hangzhou

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