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
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
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
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
Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.
Intervention: Sham Intradermal Acupuncture (Procedure)
SSRI Tapering + Intradermal Acupuncture
Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.
Intervention: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)
SSRI Tapering + Intradermal Acupuncture
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
Mingqi Tu
Doctor of Philosophy
First People's Hospital of Hangzhou