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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mingqi Tu
- Numéro de téléphone: +86 15700067213
- E-mail: 403712321@qq.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
|
Comparateur factice: 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). |
|
Expérimental: 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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SSRI Dose Reduction Rate
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in SSRI Dosage
Délai: Week 4, Week 8, Week 12
|
Absolute change in SSRI dose from baseline. |
Week 4, Week 8, Week 12
|
|
Depression Severity (HAMD-17)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Autonomic Nervous System Function (HRV Parameters)
Délai: Baseline, Week 8
|
Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring. |
Baseline, Week 8
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles de l'humeur
- Dépression
- Trouble dépressif majeur
- Effets physiologiques des drogues
- Mécanismes moléculaires d'action pharmacologique
- Agents neurotransmetteurs
- Modulateurs de transport membranaire
- Inhibiteurs de l'absorption des neurotransmetteurs
- Agents de sérotonine
- Actions pharmacologiques
- Actions et utilisations chimiques
- Inhibiteurs sélectifs du recaptage de la sérotonine
Autres numéros d'identification d'étude
- 2025KY394-1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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