Ketamine for Postherpetic Neuralgia With Depression

NCT06968624 | Not Yet Recruiting Phase 4

• 1 other identifier: TJ-IRB202503024
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

Herpetic Neuralgia; Depression; Ketamine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• 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

• 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

• McGill pain score

  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

  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

  One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy

Study Arms (2)

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.

Drug: Intravenous Ketamine Infusions; Drug: Oral Duloxetine 60mg

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.

Drug: Intravenous normal saline; Drug: Oral Duloxetine 60mg

Interventions

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.

Ketamine with Duloxetine

Intravenous normal saline DRUG

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

Normal saline with Duloxetine

Oral Duloxetine 60mg DRUG

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

Ketamine with Duloxetine; Normal saline with Duloxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wei Mei, Phd

  Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuguang Yang, MD

CONTACT

086-027-63639756; ysg101560@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 13, 2025
• Study Start: June 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share