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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Mingqi Tu
- Telefoonnummer: +86 15700067213
- E-mail: 403712321@qq.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: 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-vergelijker: 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). |
|
Experimenteel: 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). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
SSRI Dose Reduction Rate
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in SSRI Dosage
Tijdsspanne: Week 4, Week 8, Week 12
|
Absolute change in SSRI dose from baseline. |
Week 4, Week 8, Week 12
|
|
Depression Severity (HAMD-17)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Autonomic Nervous System Function (HRV Parameters)
Tijdsspanne: Baseline, Week 8
|
Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring. |
Baseline, Week 8
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Stemmingsstoornissen
- Depressieve stoornis
- Depressieve stoornis, majoor
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Neurotransmittermiddelen
- Membraantransportmodulatoren
- Neurotransmitteropnameremmers
- Serotonine agenten
- Farmacologische acties
- Chemische acties en gebruik
- Selectieve serotonineheropnameremmers
Andere studie-ID-nummers
- 2025KY394-1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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