Depression DisordersPhase 4NCT06968624
Ketamine for Postherpetic Neuralgia With Depression
A Phase 4 study testing Intravenous Ketamine Infusions, Intravenous normal saline and Oral Duloxetine 60mg in people with Depression Disorders and Herpetic Neuralgia, run by Huazhong University of Science and Technology.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Disorders, Herpetic Neuralgia
- What is being tested?
- Intravenous Ketamine Infusions, Intravenous normal saline and Oral Duloxetine 60mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 1 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study
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
- Being tested
- Intravenous Ketamine Infusions, Intravenous normal saline, Oral Duloxetine 60mg
- Keywords
- Herpetic Neuralgia, Depression, Ketamine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Ketamine InfusionsDrug
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.
Intravenous normal salineDrug
The patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes
Oral Duloxetine 60mgDrug
Patients received 60 mg/day of oral duloxetine as maintenance therapy for depression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravenous normal saline; Drug: Oral Duloxetine 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks after intravenous ketamine infusion therapy
Secondary outcomes (15)
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
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
- 40: Severe dissociation (indicative of significant impairment).
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Heart Rate
Patients' heart rate.
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Peripheral capillary oxygen saturation
One of patients' vital signs.
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Noninvasive blood pressure
Patients' noninvasive blood pressure
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Nausea
Incidence of nausea after ministration of ketamine
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Vomiting
Incidence of vomiting after administration of ketamine
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Headache
Incidence of headache after administration of ketamine
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Diplopia
Incidence of diplopia after administration of ketamine
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Hallucination
Incidence of hallucination after administration of ketamine
Measured: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, Phd, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968624
- Sponsor's protocol ID
- TJ-IRB202503024
- Status last verified
- Jun 2025
- First submitted
- 25 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06968624
- Acronym / sponsor ID
- TJ-IRB202503024
- Conditions
- Depression Disorders, Herpetic Neuralgia
- Keywords
- Herpetic Neuralgia, Depression, Ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine with Duloxetine | Experimental | Drug: Intravenous Ketamine Infusions, Drug: Oral Duloxetine 60mgPatients 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. |
| Normal saline with Duloxetine | Active comparator | Drug: Intravenous normal saline, Drug: Oral Duloxetine 60mgPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Ketamine InfusionsThe 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. | Drug | Ketamine with Duloxetine |
| Intravenous normal salineThe patients received a single intravenous infusion of 50 ml normal saline via a micro-infusion pump over 40 minutes | Drug | Normal saline with Duloxetine |
| Oral Duloxetine 60mgPatients received 60 mg/day of oral duloxetine as maintenance therapy for depression. | Drug | Ketamine with Duloxetine, Normal saline with Duloxetine |
Primary outcome
Hospital Anxiety and Depression Scale - Depression score
Time frame: 2 weeks after intravenous ketamine infusion therapy
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.
15 secondary outcomes
Montgomery-Åsberg Depression Rating Scale score
Time frame: 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
Time frame: One day, one week, two weeks, three weeks, four weeks, five weeks and six weeks after intravenous ketamine infusion therapy
McGill pain score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Clinician-Administered Dissociative States Scale score
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Heart Rate
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Peripheral capillary oxygen saturation
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Noninvasive blood pressure
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Nausea
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Vomiting
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Headache
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Diplopia
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Hallucination
Time frame: At 2 hours and 24 hours after intravenous ketamine infusion therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Mei, Phd principal investigator
Tongji Medical College, Huazhong University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Ketamine Infusions, Intravenous normal saline and Oral Duloxetine 60mg in people with Depression Disorders and Herpetic Neuralgia, run by Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuguang Yang, MD (086-027-63639756, ysg101560@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale - Depression score (time frame: 2 weeks after intravenous ketamine infusion therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.