Ketamine for Postherpetic Neuralgia With Depression

Huazhong University of Science and Technology

Status and phase: Not yet enrolling; Phase 4

Conditions: Herpetic Neuralgia; Depression Disorders

Treatments: Drug: Intravenous Ketamine Infusions; Drug: Oral Duloxetine 60mg; Drug: Intravenous normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06968624

TJ-IRB202503024

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Ketamine with Duloxetine

Experimental group

Description:

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.

Treatment:

Drug: Oral Duloxetine 60mg

Drug: Intravenous Ketamine Infusions

Normal saline with Duloxetine

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous normal saline

Drug: Oral Duloxetine 60mg