Health TrialsbyHealthPanel

Intradermal Acupuncture for Assisting SSRI Dose Reduction in Major Depressive Disorder

ConditionMajor Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFirst People's Hospital of Hangzhou

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-60 years

Disqualifiers

Severe uncontrolled primary medical conditions

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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/Surgery

    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).

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: SSRI Tapering GroupActive comparator 1 intervention
Group B: SSRI Tapering + Sham Intradermal AcupunctureSham comparator 2 interventions
Group C: SSRI Tapering + Intradermal AcupunctureExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Change in SSRI Dosage

Absolute change in SSRI dose from baseline.

Time frame
Week 4, Week 8, Week 12
2

Depression Severity (HAMD-17)

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

Time frame
Baseline, Week 4, Week 8, Week 12
3

Depression Severity (SDS)

Self-Rating Depression Scale.

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

The Asberg Rating Scale for Side Effects (SERS)

The Asberg Rating Scale for Side Effects

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First People's Hospital of Hangzhou

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: