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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mingqi Tu
- Número de teléfono: +86 15700067213
- Correo electrónico: 403712321@qq.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
|
Comparador falso: 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). |
|
Experimental: 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SSRI Dose Reduction Rate
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in SSRI Dosage
Periodo de tiempo: Week 4, Week 8, Week 12
|
Absolute change in SSRI dose from baseline. |
Week 4, Week 8, Week 12
|
|
Depression Severity (HAMD-17)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Autonomic Nervous System Function (HRV Parameters)
Periodo de tiempo: Baseline, Week 8
|
Time-domain and frequency-domain HRV parameters measured using 24-hour Holter monitoring. |
Baseline, Week 8
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos del estado de ánimo
- Desorden depresivo
- Trastorno Depresivo Mayor
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica.
- Agentes neurotransmisores
- Moduladores de transporte de membrana
- Inhibidores de la captación de neurotransmisores
- Agentes de serotonina
- Acciones farmacológicas
- Acciones y usos químicos
- Inhibidores selectivos de la recaptación de serotonina
Otros números de identificación del estudio
- 2025KY394-1
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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