Major Depressive Disorder
Conditions
Keywords
Intradermal Acupuncture, SSRIs, Heart Rate Variability
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.
Interventions
DRUGSelective 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.
PROCEDURESham 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).
PROCEDUREIntradermal 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 level tolerated by the participant. Acupoints: Shenmen (HT 7), Neiguan (PC 6), Sanyinjiao (SP 6), and Taichong (LR 3).
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSRI Dose Reduction Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in SSRI Dosage | Week 4, Week 8, Week 12 | Absolute change in SSRI dose from baseline. |
| Depression Severity (HAMD-17) | Baseline, Week 4, Week 8, Week 12 | Clinician-rated Hamilton Depression Rating Scale (17-item). |
| Depression Severity (SDS) | Baseline, Week 4, Week 8, Week 12 | Self-Rating Depression Scale. |
| The Asberg Rating Scale for Side Effects (SERS) | Baseline, Week 4, Week 8, Week 12 | The Asberg Rating Scale for Side Effects |
| Autonomic Nervous System Function (HRV Parameters) | Baseline, Week 8 | Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring. |
Contacts
CONTACTMingqi Tu
Outcome results
None listed