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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
Participants will receive only standard oral SSRI antidepressant dose reduction, with dosage adjustments determined by a specialist physician, for a duration of 8 weeks.
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).
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 Dose Reduction Rate
Percentage reduction in SSRI dosage from baseline to each assessment point, calculated as: (Baseline dose - Post-treatment dose) / Baseline dose × 100%
Time frame: Week 4, Week 8 (end of treatment), Week 12 (follow-up)
Change in SSRI Dosage
Absolute change in SSRI dose from baseline.
Time frame: Week 4, Week 8, Week 12
Depression Severity (HAMD-17)
Clinician-rated Hamilton Depression Rating Scale (17-item).
Time frame: Baseline, Week 4, Week 8, Week 12
Depression Severity (SDS)
Self-Rating Depression Scale.
Time frame: Baseline, Week 4, Week 8, Week 12
The Asberg Rating Scale for Side Effects (SERS)
The Asberg Rating Scale for Side Effects
Time frame: Baseline, Week 4, Week 8, Week 12
Discontinuation-Emergent Signs and Symptoms (DESS)
Time frame: Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.
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