"Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Hospital Anxiety and Depression Scale - Depression score
研究概览
简要总结
This clinical trial examines the antidepressant efficacy and safety of a single low-dose intravenous esketamine combined with oral duloxetine in patients with postherpetic neuralgia and depression (duration more than 1 month). In this prospective, randomized, double-blind, placebo-controlled parallel study, eligible patients were randomized into two groups: one received esketamine plus duloxetine, and the other got placebo plus duloxetine. Both groups underwent standard pain management and neuro modulation therapy. The primary outcome was the Hospital Anxiety and Depression Scale - Depression( HADS-D)score at 2 weeks post - infusion, with various secondary outcomes assessed over multiple time points. Data were collected through in-person interviews and telephone follow-ups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with herpetic neuralgia, with a disease course exceeding 1 month, and an HADS-D score ≥8 (15) upon admission.
- •Diagnosed with depression based on the DSM-V and ICD-11 criteria.
- •Aged between 18 and 65 years old.
- •BMI <30 kg/m².
排除标准
- •Unable to cooperate with questionnaires.
- •Allergic to ketamine.
- •History of other mental disorders such as anxiety.
- •Severe hypertension and serious dysfunctions of heart, lung, liver, or kidney.
研究组 & 干预措施
Ketamine with Duloxetine
Patients in this group received a single intravenous infusion of esketamine (esketamine at 0.2 mg/kg was added to 50 ml of normal saline and administered via a micro-infusion pump over 40 minutes), followed by 60 mg/day of oral duloxetine as maintenance therapy.
干预措施: Intravenous Ketamine Infusions (Drug)
Ketamine with Duloxetine
Patients in this group received a single intravenous infusion of esketamine (esketamine at 0.2 mg/kg was added to 50 ml of normal saline and administered via a micro-infusion pump over 40 minutes), followed by 60 mg/day of oral duloxetine as maintenance therapy.
干预措施: Oral Duloxetine 60mg (Drug)
Normal saline with Duloxetine
Patients in this group received a single intravenous infusion of normal saline (50 ml of normal saline administered via a micro-infusion pump over 40 minutes), followed by 60 mg/day of oral duloxetine as maintenance therapy.
干预措施: Intravenous normal saline (Drug)
Normal saline with Duloxetine
Patients in this group received a single intravenous infusion of normal saline (50 ml of normal saline administered via a micro-infusion pump over 40 minutes), followed by 60 mg/day of oral duloxetine as maintenance therapy.
干预措施: Oral Duloxetine 60mg (Drug)
结局指标
主要结局
Hospital Anxiety and Depression Scale - Depression score
时间窗: 2 weeks after intravenous ketamine infusion therapy
This scale includes 7 items, and each item is scored from 0 to 3, so the total possible score ranges from 0 to 21. The cutoff scores usually are 0-7 for normal, 8-10 for mild, 11-14 for moderate, and 15-21 for severe depression.
次要结局
- Montgomery-Åsberg Depression Rating Scale score(One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy)
- Hospital Anxiety and Depression Scale - Anxiety score(One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy)
- McGill pain score(One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy)
- NRS( Numeric Rating Scale) pain score(One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy)
- Short Form-12 Quality of Life Score(One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy)
- Columbia - Suicide Severity Rating Scale（C-SSRS）score(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Clinician-Administered Dissociative States Scale score(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Heart Rate(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Peripheral capillary oxygen saturation(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Noninvasive blood pressure(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Nausea(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Vomiting(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Headache(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Diplopia(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
- Hallucination(At 2 hours and 24 hours after intravenous ketamine infusion therapy)
研究者
Wei Mei
Professor
Huazhong University of Science and Technology