Ketamine for Postherpetic Neuralgia With Depression
- Conditions
- Depression DisordersHerpetic Neuralgia
- Interventions
- Registration Number
- NCT06968624
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketamine with Duloxetine Intravenous Ketamine Infusions 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. Ketamine with Duloxetine Oral Duloxetine 60mg 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. Normal saline with Duloxetine Intravenous normal saline 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. Normal saline with Duloxetine Oral Duloxetine 60mg 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.
- Primary Outcome Measures
Name Time Method Hospital Anxiety and Depression Scale - Depression score 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.
- Secondary Outcome Measures
Name Time Method Vomiting At 2 hours and 24 hours after intravenous ketamine infusion therapy Incidence of vomiting after administration of ketamine
Headache At 2 hours and 24 hours after intravenous ketamine infusion therapy Incidence of headache after administration of ketamine
Diplopia At 2 hours and 24 hours after intravenous ketamine infusion therapy Incidence of diplopia after administration of ketamine
Hallucination At 2 hours and 24 hours after intravenous ketamine infusion therapy Incidence of hallucination after administration of ketamine
Heart Rate At 2 hours and 24 hours after intravenous ketamine infusion therapy Patients' heart rate.
Peripheral capillary oxygen saturation At 2 hours and 24 hours after intravenous ketamine infusion therapy One of patients' vital signs.
Noninvasive blood pressure At 2 hours and 24 hours after intravenous ketamine infusion therapy Patients' noninvasive blood pressure
Nausea At 2 hours and 24 hours after intravenous ketamine infusion therapy Incidence of nausea after ministration of ketamine
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 This scale includes 10 items, each rated from 0 to 6. The total score ranges from 0 to 60. The ranges are usually 0-6 normal, 7-19 mild, 20-34 moderate, and 35-60 severe
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 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 anxiety.
McGill pain score One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy The main sections of the original MPQ are the Pain Rating Index (PRI), which includes sensory, affective, evaluative, and miscellaneous descriptors. Each category has words ranked by intensity. Then there's the Present Pain Intensity (PPI) scale, which is a 0-5 rating. Higher scores indicate more severe/intense pain
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 Rating 0-10; 0: No pain;1-3: Mild pain;4-6: Moderate pain ; 7-10: Severe pain.
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 The Short Form-12 Health Survey (SF-12) is a widely used, self-administered questionnaire designed to assess health-related quality of life. Range: 0-100 for each component. The more scores, the better quality of life.
Columbia - Suicide Severity Rating Scale（C-SSRS）score At 2 hours and 24 hours after intravenous ketamine infusion therapy The Columbia-Suicide Severity Rating Scale (C-SSRS) is a validated, clinician-administered tool designed to assess suicidal ideation and behavior.Rated on a 0-5 scale, higher scores mean higher risk of suicide.
Clinician-Administered Dissociative States Scale score At 2 hours and 24 hours after intravenous ketamine infusion therapy The Clinician-Administered Dissociative States Scale (CADSS) is a structured, clinician-administered tool designed to assess acute dissociative states in clinical and research settings. This scale includes 27 items, each item rated on a 0-4 scale, range: 0-108 .
0-19: Minimal/no dissociation. 20-39: Mild to moderate dissociation.
* 40: Severe dissociation (indicative of significant impairment).