Clinical Efficacy and Effects on Autonomic Function of Intradermal Acupuncture as an Adjunct to SSRI Tapering in Major Depressive Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 主要终点
- SSRI Dose Reduction Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
SSRI Tapering Group
Participants receive standard SSRI dose reduction or discontinuation under psychiatric supervision for 8 weeks.
干预措施: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)
SSRI Tapering + Sham Intradermal Acupuncture
Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.
干预措施: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)
SSRI Tapering + Sham Intradermal Acupuncture
Participants receive standard SSRI tapering combined with sham intradermal acupuncture for 8 weeks.
干预措施: Sham Intradermal Acupuncture (Procedure)
SSRI Tapering + Intradermal Acupuncture
Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.
干预措施: Selective Serotonin Reuptake Inhibitors (SSRIs) (Drug)
SSRI Tapering + Intradermal Acupuncture
Participants receive standard SSRI tapering combined with intradermal acupuncture for 8 weeks.
干预措施: Intradermal Acupuncture (Procedure)
结局指标
主要结局
SSRI Dose Reduction Rate
时间窗: 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%
次要结局
- The Asberg Rating Scale for Side Effects (SERS)(Baseline, Week 4, Week 8, Week 12)
- Discontinuation-Emergent Signs and Symptoms (DESS)(Scheduled assessments at Weeks 0, 4, 8, and 12, with additional symptom-triggered assessments as clinically indicated.)
- Change in SSRI Dosage(Week 4, Week 8, Week 12)
- Depression Severity (HAMD-17)(Baseline, Week 4, Week 8, Week 12)
- Depression Severity (SDS)(Baseline, Week 4, Week 8, Week 12)
研究者
Mingqi Tu
Doctor of Philosophy
First People's Hospital of Hangzhou