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.
Aged 18-60 years, irrespective of sex;
A DSM-5 diagnosis of major depressive disorder, currently in full or partial remission, clinically stable for the preceding 3 months, and not meeting the criteria for a current major depressive episode;
Continuous antidepressant treatment for at least 6 months, currently receiving a single SSRI, with the SSRI type and dose unchanged for at least 4 weeks before enrollment;
Willing to taper the SSRI and deemed clinically suitable for gradual dose reduction by a psychiatrist;
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
Parallel
Selective Serotonin Reuptake Inhibitors (SSRIs)
DrugParticipants will receive only standard oral SSRI antidepressant dose reduction, with dosage adjustments determined by a specialist physician, for a duration of 8 weeks.
Sham Intradermal Acupuncture
Procedure/SurgeryThe 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).
Intradermal Acupuncture
Procedure/SurgeryAccording 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 Dose Reduction Rate
Percentage reduction in SSRI dosage from baseline to each assessment point, calculated as: (Baseline dose - Post-treatment dose) / Baseline dose × 100%
Change in SSRI Dosage
Absolute change in SSRI dose from baseline.
Depression Severity (HAMD-17)
Clinician-rated Hamilton Depression Rating Scale (17-item).
Depression Severity (SDS)
Self-Rating Depression Scale.
The Asberg Rating Scale for Side Effects (SERS)
The Asberg Rating Scale for Side Effects
Autonomic Nervous System Function (HRV Parameters)
Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring.
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