EsketamineEarly Phase 1NCT04777110
The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy
A Early Phase 1 study testing Esketamine and Saline in people with Esketamine and ECT, run by First Affiliated Hospital of Chongqing Medical University.
Trial summary
A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety of esmketamine injection in electroconvulsive therapy Objective to evaluate the efficacy and safety of esmketamine injection in the treatment of non convulsive electroconvulsive therapy Participants: Patients with depression… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Esketamine, ECT, Depression
- What is being tested?
- Esketamine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 396 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Dec 2022
- Phase
- Early Phase 1
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Depressed patients receiving MECT for the first time;
- 16≤age≤45 years old, no gender limit;
- The ASA score is I or II;
- Meet the diagnostic criteria for depression established by APA, and the Hamilton Depression Rating Scale (HDRS-24) score ≥ 35 points;
- The depressive episode lasts at least 2 weeks;
- Clearly understand and voluntarily participate in the study, and sign an informed consent form.
Who cannot join
- Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
- There are foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
- Those with a history of epilepsy
- Those who are taking reserpine
- Acute and systemic infectious diseases, moderate or higher fever
- History of manic episodes
Show all 12Show fewer
- Those who are allergic to anesthetics and muscle relaxants
- Pregnant women
- Glaucoma
- Bipolar disorder, or other mental illnesses, mental retardation
- Those who judged by the physician in charge to be unsuitable for MECT treatment
- History of drug abuse
About this study
Official title: The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy for Depressive Patients-- A Multi-center, Randomized , Single-blind Clinical Study
A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety of esmketamine injection in electroconvulsive therapy
Objective to evaluate the efficacy and safety of esmketamine injection in the treatment of non convulsive electroconvulsive therapy
Read more
Participants: Patients with depression receiving MECT
The research drug was esketamine injection
The study design was a multicenter, randomized, single blind, parallel controlled trial
25 mg / kg as the experimental group. The normal saline group was the control group (0.05 ml / kg).
The sample size was estimated according to the main efficacy index (remission rate) of this study. It was assumed that the remission rate of the esketamine injection group was better than that of the control group. The parameters were set as test level α = 0.05, unilateral, β = 0.8, the cut-off value was 6%, the experimental group: the control group was 1:1, according to the results of previous clinical trials and combined with literature, the remission rate of the control group was 69%, 159 cases in each group, considering the 20% shedding rate, 198 cases in the experimental group and 198 cases in the control group were selected.
- experimental group The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg propofol and 1 mg / kg succinylcholine in turn. After anesthesia, the patients were given electroconvulsive therapy
- In the control group
The patients were given 0.05ml/kg of normal saline, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy
Efficacy evaluation 1. Main efficacy indicators
Remission rate of depressive symptoms after MECT treatment
Remission was defined as two consecutive hdrs-24 scores ≤ 10 after receiving MECT
Definition rate of remission rate: the proportion of patients with remission of depressive symptoms in this group
- Conditions
- Esketamine, ECT, Depression
- Being tested
- Esketamine, Saline
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
The main anesthesiologist standing on the right side of the patient injects esketamine (0.25 mg/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later for 30 s;
SalineOther
The main anesthesiologist standing on the right side of the patient injects saline (0.05ml/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30 s
| Study group | Role | What they receive |
|---|---|---|
| Esketamine injection group (0.25mg/kg) | Experimental | The main anesthesiologist standing on the right side of the patient gave successive injections of esketamine (0.25 mg/kg), and 1 minute later, injected propofol (1.5 mg/kg) for 30 s Receives: Drug: Esketamine |
| Saline injection group(0.05ml/kg) | Sham comparator | The main anesthesiologist standing on the right side of the patient sequentially injects normal saline (0.05ml/kg), and 1 minute later injects propofol (1.5 mg/kg), the injection time is 30 seconds Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief rate of depressive symptoms after MECT treatment
After the patient received MECT treatment, the HDRS-24 score ≤ 10 points for two consecutive times
Measured: immediately after the end of each ECT procedure
Secondary outcomes (6)
HDRS-24 score after each MECT
HDRS-24 score after each MECT
Measured: Immediately after the end of ECT, four months and six months after the end of the entire treatment course
Treatment response rate
Response is defined as two consecutive HDRS-24 scores ≤ 50% before treatment after receiving MECT treatment. Effectiveness is defined as the proportion of patients in the group that are treated effectively
Measured: through treatment completion, an average of 18 days
Severe suicidal tendency elimination rate
Severe suicidal tendency is defined as the suicide item score in HDRS-24 ≥ 3 points. The elimination rate of severe suicidal tendency was defined as the proportion of patients with suicide score=0 after treatment in the proportion of patients with severe suicidal tendency
Measured: through treatment completion, an average of 18 days
Treatment re-ignition rate
Re-ignition is defined as an increase in HDRS-24 score of ≥ 10 points within 4 months of patients in remission. The re-ignition rate is defined as the proportion of re-ignition patients in remission patients.
Measured: within 4 months of patients in remission
Treatment recurrence rate
The HDRS-24 score increased by ≥10 points after 4 months for patients whose recurrence is positioned as remission. The recurrence rate is defined as the proportion of relapsed patients in remission.
Measured: up to 4 months
Changes in cognitive function
Montreal Cognitive Scale (MoCA) assessment
Measured: Immediately after the end of ECT, four months and six months after the end of the entire treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study startAug 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsketamineStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777110
- Sponsor's protocol ID
- ESK-ECT20210222
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2021
- Last updated
- 20 Jul 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 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy for Depressive Patients-- A Multi-center, Randomized , Single-blind Clinical Study
- ClinicalTrials.gov ID
- NCT04777110
- Acronym / sponsor ID
- ESK-ECT20210222
- Conditions
- Esketamine, ECT, Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Mar 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.
A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety of esmketamine injection in electroconvulsive therapy
Objective to evaluate the efficacy and safety of esmketamine injection in the treatment of non convulsive electroconvulsive therapy
Participants: Patients with depression receiving MECT
The research drug was esketamine injection
The study design was a multicenter, randomized, single blind, parallel controlled trial
25 mg / kg as the experimental group. The normal saline group was the control group (0.05 ml / kg).
The sample size was estimated according to the main efficacy index (remission rate) of this study. It was assumed that the remission rate of the esketamine injection group was better than that of the control group. The parameters were set as test level α = 0.05, unilateral, β = 0.8, the cut-off value was 6%, the experimental group: the control group was 1:1, according to the results of previous clinical trials and combined with literature, the remission rate of the control group was 69%, 159 cases in each group, considering the 20% shedding rate, 198 cases in the experimental group and 198 cases in the control group were selected.
- experimental group The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg propofol and 1 mg / kg succinylcholine in turn. After anesthesia, the patients were given electroconvulsive therapy
- In the control group
The patients were given 0.05ml/kg of normal saline, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy
Efficacy evaluation 1. Main efficacy indicators
Remission rate of depressive symptoms after MECT treatment
Remission was defined as two consecutive hdrs-24 scores ≤ 10 after receiving MECT
Definition rate of remission rate: the proportion of patients with remission of depressive symptoms in this group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine injection group (0.25mg/kg) | Experimental | Drug: EsketamineThe main anesthesiologist standing on the right side of the patient gave successive injections of esketamine (0.25 mg/kg), and 1 minute later, injected propofol (1.5 mg/kg) for 30 s |
| Saline injection group(0.05ml/kg) | Sham comparator | Other: SalineThe main anesthesiologist standing on the right side of the patient sequentially injects normal saline (0.05ml/kg), and 1 minute later injects propofol (1.5 mg/kg), the injection time is 30 seconds |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Depressed patients receiving MECT for the first time;
- 16≤age≤45 years old, no gender limit;
- The ASA score is I or II;
- Meet the diagnostic criteria for depression established by APA, and the Hamilton Depression Rating Scale (HDRS-24) score ≥ 35 points;
- The depressive episode lasts at least 2 weeks;
Key exclusion criteria (12 listed)
- Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
- There are foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
- Those with a history of epilepsy
- Those who are taking reserpine
- Acute and systemic infectious diseases, moderate or higher fever
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 |
|---|---|---|
| EsketamineThe main anesthesiologist standing on the right side of the patient injects esketamine (0.25 mg/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later for 30 s; | Drug | Esketamine injection group (0.25mg/kg) |
| SalineThe main anesthesiologist standing on the right side of the patient injects saline (0.05ml/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30 s | Other | Saline injection group(0.05ml/kg) |
Primary outcome
Relief rate of depressive symptoms after MECT treatment
Time frame: immediately after the end of each ECT procedure
After the patient received MECT treatment, the HDRS-24 score ≤ 10 points for two consecutive times
6 secondary outcomes
HDRS-24 score after each MECT
Time frame: Immediately after the end of ECT, four months and six months after the end of the entire treatment course
Treatment response rate
Time frame: through treatment completion, an average of 18 days
Severe suicidal tendency elimination rate
Time frame: through treatment completion, an average of 18 days
Treatment re-ignition rate
Time frame: within 4 months of patients in remission
Treatment recurrence rate
Time frame: up to 4 months
Changes in cognitive function
Time frame: Immediately after the end of ECT, four months and six months after the end of the entire treatment course
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Esketamine and Saline in people with Esketamine and ECT, run by First Affiliated Hospital of Chongqing Medical 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 6 inclusion and 12 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 20 Jul 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief rate of depressive symptoms after MECT treatment (time frame: immediately after the end of each ECT procedure). 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 20 Jul 2021.