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NCT Number: NCT07390981

Intradermal Acupuncture for Assisting SSRI Dose Reduction in Major Depressive Disorder

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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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

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).

Primary outcomes

  1. SSRI Dose Reduction Rate

    Time frame: 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 outcomes

  1. Change in SSRI Dosage

    Time frame: Week 4, Week 8, Week 12

    Absolute change in SSRI dose from baseline.

  2. Depression Severity (HAMD-17)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Clinician-rated Hamilton Depression Rating Scale (17-item).

  3. Depression Severity (SDS)

    Time frame: Baseline, Week 4, Week 8, Week 12

    Self-Rating Depression Scale.

  4. The Asberg Rating Scale for Side Effects (SERS)

    Time frame: Baseline, Week 4, Week 8, Week 12

    The Asberg Rating Scale for Side Effects

  5. Autonomic Nervous System Function (HRV Parameters)

    Time frame: Baseline, Week 8

    Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingqi Tu

CONTACT

[email protected]

+86 15700067213

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

Clinical Efficacy of Intradermal Acupuncture as an Adjunct to SSRI Dose Reduction or Discontinuation in Patients With Major Depressive Disorder and Its Mechanisms of Autonomic Nervous System Regulation

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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