Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder
Clinical Efficacy and Effects on Autonomic Function of Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder: A Randomized Controlled 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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mingqi Tu
- Telefonnummer: +86 15700067213
- E-mail: 403712321@qq.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 18-60 years, irrespective of sex;
- A DSM-5 diagnosis of major depressive disorder, currently in full or partial remission, clinically stable for the preceding 3 months, and not meeting the criteria for a current major depressive episode;
- Continuous antidepressant treatment for at least 6 months, currently receiving a single SSRI, with the SSRI type and dose unchanged for at least 4 weeks before enrollment;
- Willing to taper the SSRI and deemed clinically suitable for gradual dose reduction by a psychiatrist;
- Provision of 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: SSRI Tapering Group
Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks. |
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-komparator: SSRI Tapering + Sham Intradermal Acupuncture
Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks. |
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). |
|
Eksperimentel: SSRI Tapering + Intradermal Acupuncture
Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks. |
Participants will receive only standard oral SSRI antidepressant dose reduction, with dosage adjustments determined by a specialist physician, for a duration of 8 weeks. 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SSRI Dose Reduction Rate
Tidsramme: 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% |
Week 4, Week 8 (end of treatment), Week 12 (follow-up)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in SSRI Dosage
Tidsramme: Week 4, Week 8, Week 12
|
Absolute change in SSRI dose from baseline. |
Week 4, Week 8, Week 12
|
|
Depression Severity (HAMD-17)
Tidsramme: Baseline, Week 4, Week 8, Week 12
|
Clinician-rated Hamilton Depression Rating Scale (17-item). |
Baseline, Week 4, Week 8, Week 12
|
|
Depression Severity (SDS)
Tidsramme: Baseline, Week 4, Week 8, Week 12
|
Self-Rating Depression Scale. |
Baseline, Week 4, Week 8, Week 12
|
|
The Asberg Rating Scale for Side Effects (SERS)
Tidsramme: Baseline, Week 4, Week 8, Week 12
|
The Asberg Rating Scale for Side Effects |
Baseline, Week 4, Week 8, Week 12
|
|
Discontinuation-Emergent Signs and Symptoms (DESS)
Tidsramme: Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.
|
Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Autonomic Nervous System Function (HRV Parameters)
Tidsramme: Baseline, Week 8
|
Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring. |
Baseline, Week 8
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Stemningsforstyrrelser
- Depressiv lidelse
- Depressiv lidelse, major
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Neurotransmittermidler
- Membrantransportmodulatorer
- Neurotransmitter optagelseshæmmere
- Serotoninmidler
- Farmakologiske handlinger
- Kemiske handlinger og anvendelser
- Selektive Serotonin-genoptagelseshæmmere
Andre undersøgelses-id-numre
- 2025KY394-1
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