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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine with Duloxetine | Experimental | 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. |
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| Normal saline with Duloxetine | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Ketamine Infusions | Drug | The patients received a single intravenous infusion of esketamine (0.2 mg/kg), which was added to 50 ml of normal saline and administered via a micro-infusion pump over 40 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale - Depression score | 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. | 2 weeks after intravenous ketamine infusion therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale score | 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 | One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuguang Yang, MD | Contact | 086-027-63639756 | ysg101560@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wei Mei, Phd | Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Intravenous normal saline | Drug | The patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes |
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| Oral Duloxetine 60mg | Drug | Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression. |
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| Hospital Anxiety and Depression Scale - Anxiety score | 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. | One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy |
| McGill pain score | 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 | 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 | Rating 0-10; 0: No pain;1-3: Mild pain;4-6: Moderate pain ; 7-10: Severe pain. | 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 | 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. | 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 | 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. | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Clinician-Administered Dissociative States Scale score | 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.
| At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Heart Rate | Patients' heart rate. | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Peripheral capillary oxygen saturation | One of patients' vital signs. | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Noninvasive blood pressure | Patients' noninvasive blood pressure | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Nausea | Incidence of nausea after ministration of ketamine | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Vomiting | Incidence of vomiting after administration of ketamine | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Headache | Incidence of headache after administration of ketamine | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Diplopia | Incidence of diplopia after administration of ketamine | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| Hallucination | Incidence of hallucination after administration of ketamine | At 2 hours and 24 hours after intravenous ketamine infusion therapy |
| D006571 |
| Heterocyclic Compounds |