Clinical trial NCT06968624: Ketamine for Postherpetic Neuralgia With Depression
Official title: "Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Depression Disorders
Herpetic Neuralgia
Keywords: Herpetic Neuralgia
Depression
Ketamine
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale - Depression score
timeFrame: 2 weeks after intravenous ketamine infusion therapy
Secondary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale score
timeFrame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy
measure: Hospital Anxiety and Depression Scale - Anxiety score
timeFrame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy
measure: McGill pain score
timeFrame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy
measure: NRS( Numeric Rating Scale) pain score
timeFrame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy
measure: Short Form-12 Quality of Life Score
timeFrame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy
measure: Columbia - Suicide Severity Rating Scale（C-SSRS）score
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Clinician-Administered Dissociative States Scale score
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Heart Rate
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Peripheral capillary oxygen saturation
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Noninvasive blood pressure
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Nausea
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Vomiting
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Headache
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Diplopia
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
measure: Hallucination
timeFrame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Other outcomes:
Locations:
Study officials:
affiliation: Tongji Medical College, Huazhong University of Science and Technology
name: Wei Mei, Phd
role: PRINCIPAL_INVESTIGATOR
References: