Intradermal Acupuncture for Assisting SSRI Dose Reduction in Major Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective Serotonin Reuptake Inhibitors (SSRIs), Sham Intradermal Acupuncture, Intradermal Acupuncture.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 lev
Primary outcome measures
- SSRI Dose Reduction Rate [Time frame: Week 4, Week 8 (end of treatment), Week 12 (follow-up)]
Secondary outcome measures (5)
- Change in SSRI Dosage [Time frame: Week 4, Week 8, Week 12]
- Depression Severity (HAMD-17) [Time frame: Baseline, Week 4, Week 8, Week 12]
- Depression Severity (SDS) [Time frame: Baseline, Week 4, Week 8, Week 12]
- The Asberg Rating Scale for Side Effects (SERS) [Time frame: Baseline, Week 4, Week 8, Week 12]
- Autonomic Nervous System Function (HRV Parameters) [Time frame: Baseline, Week 8]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07390981 · 2025KY394-1