Intradermal Acupuncture for Assisting SSRI Dose Reduction in Major Depressive Disorder

Zhejiang University

Status: Begins enrollment this month

Conditions: Major Depressive Disorder

Treatments: Drug: Selective Serotonin Reuptake Inhibitors (SSRIs); Procedure: Intradermal Acupuncture; Procedure: Sham Intradermal Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07390981

2025KY394-1

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 3 patient groups

SSRI Tapering Group

Active Comparator group

Description:

Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks.

Treatment:

Drug: Selective Serotonin Reuptake Inhibitors (SSRIs)

SSRI Tapering + Sham Intradermal Acupuncture

Sham Comparator group

Description:

Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.

Treatment:

Procedure: Sham Intradermal Acupuncture

Drug: Selective Serotonin Reuptake Inhibitors (SSRIs)

SSRI Tapering + Intradermal Acupuncture

Experimental group

Description:

Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.

Treatment:

Procedure: Intradermal Acupuncture

Drug: Selective Serotonin Reuptake Inhibitors (SSRIs)