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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSRI Tapering Group | Active Comparator | Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks. |
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| SSRI Tapering + Sham Intradermal Acupuncture | Sham Comparator | Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks. |
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| SSRI Tapering + Intradermal Acupuncture | Experimental | Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective Serotonin Reuptake Inhibitors (SSRIs) | Drug | Participants will receive only standard oral SSRI antidepressant dose reduction, with dosage adjustments determined by a specialist physician, for a duration of 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | Week 4, Week 8 (end of treatment), Week 12 (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SSRI Dosage | Absolute change in SSRI dose from baseline. | Week 4, Week 8, Week 12 |
| Depression Severity (HAMD-17) | Clinician-rated Hamilton Depression Rating Scale (17-item). |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingqi Tu | Contact | +86 15700067213 | 403712321@qq.com |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Sham Intradermal Acupuncture | Procedure | 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). |
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| Intradermal Acupuncture | Procedure | 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). |
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| Baseline, Week 4, Week 8, Week 12 |
| Depression Severity (SDS) | Self-Rating Depression Scale. | Baseline, Week 4, Week 8, Week 12 |
| The Asberg Rating Scale for Side Effects (SERS) | The Asberg Rating Scale for Side Effects | Baseline, Week 4, Week 8, Week 12 |
| Autonomic Nervous System Function (HRV Parameters) | Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring. | Baseline, Week 8 |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |