Chronic Visceral PainNCT04847245
Esketamine Adjuvant Therapy for Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder
A study testing Pregabalin 75mg tid + Duloxetine, Intravenous administration of esketamine 0.125 mg/kg+Duloxetine and Intravenous administration of esketamine 0.25 mg/kg +Duloxetine in people with Chronic Visceral Pain and Major Depressive Disorder, run by Peking University.
Trial summary
Ketamine is a dissociative anesthetic and powerful analgesic. At low doses, ketamine can desensitize the central pain pathway and modulate opioid receptors. Studies have generally found that preoperative use of ketamine can reduce opioid consumption by approximately 50% and sub-anaesthetic doses of it have a rapid… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Visceral Pain, Major Depressive Disorder
- What is being tested?
- Pregabalin 75mg tid + Duloxetine, Intravenous administration of esketamine 0.125 mg/kg+Duloxetine and Intravenous administration of esketamine 0.25 mg/kg +Duloxetine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18 to 55
- Those who can understand and obey the research plan
- Sign the informed consent form voluntarily
- Those who meet the DSM-IV-TR depression diagnostic criteria and have first or second episodes of depression
- Hamilton Depression Scale score ≥ 14 points
- Those who meet the ICD-11 pain diagnostic criteria, and visual analogue scale score ≥ 7 points. Those who have chronic visceral pain instead of cancer pain.
- No systemic use of antidepressants and analgesics within 2 weeks after enrollment.
- -
Who cannot join
- Female patients who are pregnant, breastfeeding, or preparing to conceive
- Allergic to duloxetine or pregabalin in the past.
- A history of serious or unstable physical diseases, such as cardiovascular/liver/kidney/respiratory/ endocrine/nervous/ blood system disease.
- A history of epileptic seizures or brain injury, or any neurological disease (including multiple sclerosis, degenerative diseases such as acute lateral sclerosis, Parkinson's disease and movement disorders, etc.);
- In the last 12 months, the patient has the following medical history or its main diagnosis (DSM-IV-TR) is organic mental disorder, schizophrenia, schizoaffective mental disorder, delusional mental disorder, indeterminate mental disorder, Bipolar disorder, psychotic characteristics that are coordinated or uncoordinated with the mood, and history of substance abuse (including alcohol, psychoactive substances, etc.).
- Patients with a history of adverse reactions to multiple drugs.
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- The patient is taking psychotropic drugs, including benzodiazepines, sleeping pills, anticonvulsants, etc.
- During the depressive episode, treatment with at least 2 antidepressants in a sufficient course of treatment or at least one SSRI antidepressant treatment is ineffective. A sufficient dose of treatment means treatment with fluoxetine ≥40 mg/day (or sertraline ≥100 mg/day, paroxetine> 40 mg/day, fluvoxamine> 100 mg/day, citalopram> 40 mg /Day, escitalopram> 20 mg/day, venlafaxine> 150 mg/day, duloxetine> 80 mg/day)
- Received electroconvulsive therapy within 6 months before enrollment.
- Those who are currently at serious risk of suicide, and a score of 3 or higher in item 3 of the 17-HAMD .
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled, Single-blind, Esketamine Adjuvant Therapy for the Efficacy and Safety of Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder
Ketamine is a dissociative anesthetic and powerful analgesic. At low doses, ketamine can desensitize the central pain pathway and modulate opioid receptors. Studies have generally found that preoperative use of ketamine can reduce opioid consumption by approximately 50% and sub-anaesthetic doses of it have a rapid antidepressant effect, especially refractory depression. Studies have confirmed that esketamine, the S(+) enantiomer of ketamine, has a stronger affinity for NMDA receptors, which can achieve the same effect at smaller doses. While the incidence of neuropsychiatric side effects is significantly lower. On March 4, 2019, the U.S. Food and Drug Administration (FDA) first approved esketamine nasal spray with a new mechanism of action for the treatment of adult patients with refractory depression. Based on the analgesic and antidepressant effects of ketamine, the investigators speculate that esketamine may be effective for patients with chronic visceral pain comorbid depression. At present, the research evidence in this area is relatively lacking. Therefore, this study aims to explore the difference in the efficacy and safety of esketamine as an adjuvant therapy and positive control drug-pregabalin in patients with chronic visceral pain comorbid depression.
Detailed Description: According to the inclusion criteria and exclusion criteria, select patients with chronic visceral pain comorbid depression.
Read more
Filtering and grouping period: During this phase, the patient will sign an informed consent form, and then conduct a structured clinical evaluation to determine whether it meets the "depressive disorder" in the DSM-IV-TR diagnostic criteria. According to the ICD-11, determine whether the patients have chronic visceral pain.
Acute treatment period: Randomize patients into the following treatment groups: intravenous administration of esketamine (3 groups, 0.125, 0.25, 0.50 mg/kg)， and duloxetine is co- administered orally. Pregabalin capsules were administered combined with duloxetine orally.
observation period: After 2 weeks, esketamine treatment was discontinued, and observation was continued for 2 weeks. Maintain duloxetine and pregabalin treatment.
- Conditions
- Chronic Visceral Pain, Major Depressive Disorder
- Being tested
- Pregabalin 75mg tid + Duloxetine, Intravenous administration of esketamine 0.125 mg/kg+Duloxetine, Intravenous administration of esketamine 0.25 mg/kg +Duloxetine, Intravenous administration of esketamine 0.50 mg/kg+Duloxetine
- Keywords
- Esketamine, Pregabalin, Efficacy and Safety, Chronic Visceral Pain, Major depressive disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mg tid + DuloxetineDrug
Pregabalin capsules were administered orally (75 mg, 3 times a day), combined administration of duloxetine (60-120 mg/day）.
Intravenous administration of esketamine 0.125 mg/kg+DuloxetineDrug
Intravenous administration of esketamine 0.125 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day）
Intravenous administration of esketamine 0.25 mg/kg +DuloxetineDrug
Intravenous administration of esketamine 0.25 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day）
Intravenous administration of esketamine 0.50 mg/kg+DuloxetineDrug
Intravenous administration of esketamine 0.50 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day）
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Active comparator | Pregabalin capsules were administered orally (75 mg, tid), combined administration of duloxetine. Receives: Drug: Pregabalin 75mg tid + Duloxetine |
| 0.125 mg/kg esketamine group | Experimental | Intravenous administration of esketamine 0.125 mg/kg，and duloxetine is co- administered orally. Receives: Drug: Intravenous administration of esketamine 0.125 mg/kg+Duloxetine |
| 0.25 mg/kg esketamine group | Experimental | Intravenous administration of esketamine 0.25mg/kg，and duloxetine is co- administered orally. Receives: Drug: Intravenous administration of esketamine 0.25 mg/kg +Duloxetine |
| 0.50 mg/kg esketamine group | Experimental | Intravenous administration of esketamine 0.50 mg/kg，and duloxetine is co- administered orally. Receives: Drug: Intravenous administration of esketamine 0.50 mg/kg+Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with chronic visceral pain. The minimus value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: Day 0 to Day 28
Secondary outcomes (6)
Hamilton Depression Rating Scale (HAMD)
The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The minimum value is 0 and the maximum value is 52. Higher scores mean a worse outcome.
Measured: Day 0 to Day 28
Short Form 12 Health Survey (SF-12)
SF-12 is a 12-item, patient-reported survey of patient health, and is widely used since it produces similar results for physical and mental health scores with far less respondent burden for producing scores of overall mental and physical well-being. The SF-12 yields an eight-scale profile of scores as well as physical and mental health summary measures. Answers to questions of these subscales are combined (weighted) with Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scale scores. SF-12 scales and summary measures are scored so that a higher score indicates a better health state. After recoding raw scores for some items (BP, GH, VT, and one item from MH), the raw scores could be transformed to provide scores for eight scales, each ranging from 0 (the worst) to 100 (the best).
Measured: Day 0 to Day 28
Hamilton Anxiety Scale (HAMA)
The HAMA is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe. The minimum value is 0 and the maximum value is 56. Higher scores mean a worse outcome.
Measured: Day 0 to Day 28
Changes in serum inflammatory factors
Explore the action mechanism of esketamine on patients with chronic visceral pain comorbid depression from the level of blood inflammatory factors, including cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12p70, TNF-alpha, etc.
Measured: Day 0 to Day 28
Electroencephalogram (EEG)
Calculate the time-frequency characteristics of EEG data in each frequency band (delta wave, <4 Hz; theta wave, 4-8 Hz; alpha wave, 8-12 Hz and beta wave, 12-30 Hz) during the study period.
Measured: Day 0 to Day 28
Functional magnetic resonance imaging (fMRI)
The regional brain activity, including fractional amplitude of low frequency fluctuation (fALFF) and regional homogeneity (ReHo) values, will be computed and assessed. In addtion, the large-scale brain networks and edge-wise connections in patients will be explored based on the theory of brain networks during the study period.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Visceral PainStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847245
- Sponsor's protocol ID
- Esketamine20210221
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Single-blind, Esketamine Adjuvant Therapy for the Efficacy and Safety of Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04847245
- Acronym / sponsor ID
- Esketamine20210221
- Conditions
- Chronic Visceral Pain, Major Depressive Disorder
- Keywords
- Esketamine, Pregabalin, Efficacy and Safety, Chronic Visceral Pain, Major depressive disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 19 Apr 2021 (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.
Ketamine is a dissociative anesthetic and powerful analgesic. At low doses, ketamine can desensitize the central pain pathway and modulate opioid receptors. Studies have generally found that preoperative use of ketamine can reduce opioid consumption by approximately 50% and sub-anaesthetic doses of it have a rapid antidepressant effect, especially refractory depression. Studies have confirmed that esketamine, the S(+) enantiomer of ketamine, has a stronger affinity for NMDA receptors, which can achieve the same effect at smaller doses. While the incidence of neuropsychiatric side effects is significantly lower. On March 4, 2019, the U.S. Food and Drug Administration (FDA) first approved esketamine nasal spray with a new mechanism of action for the treatment of adult patients with refractory depression. Based on the analgesic and antidepressant effects of ketamine, the investigators speculate that esketamine may be effective for patients with chronic visceral pain comorbid depression. At present, the research evidence in this area is relatively lacking. Therefore, this study aims to explore the difference in the efficacy and safety of esketamine as an adjuvant therapy and positive control drug-pregabalin in patients with chronic visceral pain comorbid depression.
Detailed Description: According to the inclusion criteria and exclusion criteria, select patients with chronic visceral pain comorbid depression.
Filtering and grouping period: During this phase, the patient will sign an informed consent form, and then conduct a structured clinical evaluation to determine whether it meets the "depressive disorder" in the DSM-IV-TR diagnostic criteria. According to the ICD-11, determine whether the patients have chronic visceral pain.
Acute treatment period: Randomize patients into the following treatment groups: intravenous administration of esketamine (3 groups, 0.125, 0.25, 0.50 mg/kg)， and duloxetine is co- administered orally. Pregabalin capsules were administered combined with duloxetine orally.
observation period: After 2 weeks, esketamine treatment was discontinued, and observation was continued for 2 weeks. Maintain duloxetine and pregabalin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Active comparator | Drug: Pregabalin 75mg tid + DuloxetinePregabalin capsules were administered orally (75 mg, tid), combined administration of duloxetine. |
| 0.125 mg/kg esketamine group | Experimental | Drug: Intravenous administration of esketamine 0.125 mg/kg+DuloxetineIntravenous administration of esketamine 0.125 mg/kg，and duloxetine is co- administered orally. |
| 0.25 mg/kg esketamine group | Experimental | Drug: Intravenous administration of esketamine 0.25 mg/kg +DuloxetineIntravenous administration of esketamine 0.25mg/kg，and duloxetine is co- administered orally. |
| 0.50 mg/kg esketamine group | Experimental | Drug: Intravenous administration of esketamine 0.50 mg/kg+DuloxetineIntravenous administration of esketamine 0.50 mg/kg，and duloxetine is co- administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- aged 18 to 55
- Those who can understand and obey the research plan
- Sign the informed consent form voluntarily
- Those who meet the DSM-IV-TR depression diagnostic criteria and have first or second episodes of depression
- Hamilton Depression Scale score ≥ 14 points
Key exclusion criteria (11 listed)
- Female patients who are pregnant, breastfeeding, or preparing to conceive
- Allergic to duloxetine or pregabalin in the past.
- A history of serious or unstable physical diseases, such as cardiovascular/liver/kidney/respiratory/ endocrine/nervous/ blood system disease.
- A history of epileptic seizures or brain injury, or any neurological disease (including multiple sclerosis, degenerative diseases such as acute lateral sclerosis, Parkinson's disease and movement disorders, etc.);
- In the last 12 months, the patient has the following medical history or its main diagnosis (DSM-IV-TR) is organic mental disorder, schizophrenia, schizoaffective mental disorder, delusional mental disorder, indeterminate mental disorder, Bipolar disorder, psychotic characteristics that are coordinated or uncoordinated with the mood, and history of substance abuse (including alcohol, psychoactive substances, etc.).
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 |
|---|---|---|
| Pregabalin 75mg tid + DuloxetinePregabalin capsules were administered orally (75 mg, 3 times a day), combined administration of duloxetine (60-120 mg/day）. | Drug | Pregabalin group |
| Intravenous administration of esketamine 0.125 mg/kg+DuloxetineIntravenous administration of esketamine 0.125 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day） | Drug | 0.125 mg/kg esketamine group |
| Intravenous administration of esketamine 0.25 mg/kg +DuloxetineIntravenous administration of esketamine 0.25 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day） | Drug | 0.25 mg/kg esketamine group |
| Intravenous administration of esketamine 0.50 mg/kg+DuloxetineIntravenous administration of esketamine 0.50 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day） | Drug | 0.50 mg/kg esketamine group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Day 0 to Day 28
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with chronic visceral pain. The minimus value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
6 secondary outcomes
Hamilton Depression Rating Scale (HAMD)
Time frame: Day 0 to Day 28
Short Form 12 Health Survey (SF-12)
Time frame: Day 0 to Day 28
Hamilton Anxiety Scale (HAMA)
Time frame: Day 0 to Day 28
Changes in serum inflammatory factors
Time frame: Day 0 to Day 28
Electroencephalogram (EEG)
Time frame: Day 0 to Day 28
Functional magnetic resonance imaging (fMRI)
Time frame: Day 0 to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Pregabalin 75mg tid + Duloxetine, Intravenous administration of esketamine 0.125 mg/kg+Duloxetine and Intravenous administration of esketamine 0.25 mg/kg +Duloxetine in people with Chronic Visceral Pain and Major Depressive Disorder, run by Peking University.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianmei SI, PhD., MD (86-1062723748, si.tian-mei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Day 0 to Day 28). 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 19 Apr 2021.