Ketamine for Postherpetic Neuralgia With Depression

NCT ID: NCT06968624

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-06-01

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.

Conditions

Depression Disorders; Herpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intravenous Ketamine Infusions

Intervention Type: 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.

Oral Duloxetine 60mg

Intervention Type: DRUG

Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression.

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.

Group Type: ACTIVE_COMPARATOR

Intravenous normal saline

Intervention Type: DRUG

The patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes

Oral Duloxetine 60mg

Intervention Type: DRUG

Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression.

Interventions

Intravenous Ketamine Infusions

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.

Intervention Type: DRUG

Intravenous normal saline

The patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes

Intervention Type: DRUG

Oral Duloxetine 60mg

Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Wei Mei

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Mei, Phd

Role: PRINCIPAL_INVESTIGATOR

Tongji Medical College, Huazhong University of Science and Technology

Central Contacts

Shuguang Yang, MD

Role: CONTACT

ysg101560@hust.edu.cn

086-027-63639756

Other Identifiers

TJ-IRB202503024

Identifier Type: -

Identifier Source: org_study_id