An interventional study of Selective Serotonin Reuptake Inhibitors (SSRIs) and Sham Intradermal Acupuncture in Major Depressive Disorder, sponsored by First People's Hospital of Hangzhou. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 114 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks.
Drug: Selective Serotonin Reuptake Inhibitors (SSRIs)
Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.
Drug: Selective Serotonin Reuptake Inhibitors (SSRIs) · Procedure: Sham Intradermal Acupuncture
Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.
Drug: Selective Serotonin Reuptake Inhibitors (SSRIs) · Procedure: Intradermal Acupuncture
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.
Autonomic Nervous System Function (HRV Parameters)
Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring.
Time frame: Baseline, Week 8
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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First People's Hospital of Hangzhou