EsketamineEarly Phase 1NCT07247968
Subanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study
A Early Phase 1 study testing Esketamine injection group (0.25 mg/kg) and Saline injection group (Consistent with esketamine injection volume) in people with Esketamine and ECT, run by Min Su at 2 sites in China.
Trial summary
The study design was a randomized, double blind, parallel controlled trial.The goal of this clinical trial is to learn if esketamine-assisted modified electroconvulsive therapy (ESK-MECT) works to treat severe depression in adolescents. It will also learn about the safety of ESK-MECT. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Esketamine, ECT, Depression
- What is being tested?
- Esketamine injection group (0.25 mg/kg) and Saline injection group (Consistent with esketamine injection volume)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesChina
- Study dates
- 25 Nov 2025to 20 Dec 2026
- Phase
- Early Phase 1
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inpatients diagnosed with Major Depressive Disorder according to the International Classification of Diseases,11th Revision(ICD-11),and scheduled for Modified Electroconvulsive Therapy(MECT);
- Aged 13 to 17 years,regardless of gender;
- Educational attainment of primary school or higher;
- Normal hearing and vision,including color perception;
- Voluntary participation in the study with signed informed consent;
- American Society of Anesthesiologists(ASA)physical status classification I-II.
Who cannot join
- Severe cardiovascular disease,significant arrhythmias,or other cardiac conditions;
- Inability to complete the assessment scales;
- History of substance abuse;
- Received electroconvulsive therapy(ECT)within 6 months prior to the study;
- Severe cerebrovascular disease,severe hypertension,intracranial hypertension,or presence of intracranial electrodes;
- Severe allergy or contraindication to propofol or succinylcholine;
- Comorbid with other psychiatric disorders.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Su Min, MD, +86-23-89011068, ms89011068@163.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Su Min, 0086-023-89011876, ms89011068@163.com
About this study
Official title: Clinical and Mechanistic Study of Subanesthetic-dose Esketamine in Modified Electroconvulsive Therapy for Adolescents With Severe Depression
The study design was a randomized, double blind, parallel controlled trial.The goal of this clinical trial is to learn if esketamine-assisted modified electroconvulsive therapy (ESK-MECT) works to treat severe depression in adolescents. It will also learn about the safety of ESK-MECT.
The sample size was calculated based on the response rate of patients with depression undergoing electroconvulsive therapy(ECT).According to the results of the pilot study,the efficacy rate of subjects receiving adjunctive esketamine was approximately 78%,while the efficacy rate of those receiving only propofol was 63%.The expected superiority difference in remission rates between the two groups was 15%(one-sided)for the power calculation.Assuming a significance level of α=0.05 and a test power of β=0.2,with a 1:1 ratio of sample sizes between the two groups,the total sample size was calculated to be 198 using the PASS software(PASS 2023).Considering a dropout rate of 10%,a total of 220 subjects were required,with 110 subjects in each group.
Read more
- 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 normal saline consistent with esketamine injection volume, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy.
Efficacy evaluation 1. Main efficacy indicators Response rate of depressive symptoms after MECT treatment Response is defined as two consecutive HAMD-24 scores ≤ 50% before treatment after receiving MECT treatment. The response rate is calculated as the number of patients who achieved as response divided by the total number of patients receiving MECT.In this study, the 24-item version of HAMD was utilized.
Participants will:
Be randomly assigned to the esketamine group or the control group, and receive standard MECT treatment.
Have seizure parameters, seizure duration, vital signs, and complications recorded.
Complete psychiatric scale assessments, including HAMD-24, BSS, PANSS, WMS-RC and MoCA.
Be assessed at the following time points: HAMD-24 and BSS after each treatment; PANSS after each treatment course;WMS-RC and MoCA before MECT and after one treatment course.
All subjects did not discontinue antidepressants before modified electroconvulsive therapy(MECT),and they were fasting for 8 hours and no fluids for 2 hours.Three minutes before MECT,continuous qCON monitoring(Apollo-9000A,Chongqing Xideer Medical Equipment Co.,Ltd.,China)was initiated,while monitoring blood pressure,heart rate,and peripheral capillary oxygen saturation.Preoxygenation was administered for 3 minutes.The qCON monitor uses three electrodes on the forehead to collect raw electroencephalogram(EEG)signals.The qCON monitoring includes the qCON index,qNOX index,burst suppression(BS),and signal quality index(SQI).
- Conditions
- Esketamine, ECT, Depression, Adolescent
- Being tested
- Esketamine injection group (0.25 mg/kg), Saline injection group (Consistent with esketamine injection volume)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine injection group (0.25 mg/kg)Drug
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.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness.
Saline injection group (Consistent with esketamine injection volume)Other
The main anesthesiologist standing on the right side of the patient injects saline (Consistent with esketamine injection volume) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness.
| 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 (1.5mg/kg) for 30 s.After the loss of consciousness, all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness. Receives: Drug: Esketamine injection group (0.25 mg/kg) |
| Saline injection group(Consistent with esketamine injection volume) | Sham comparator | The main anesthesiologist standing on the right side of the patient gave successive injections of saline (Consistent with esketamine injection volume), and 1 minute later, injected 1.5mg/kg of propofol in 30s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness. Receives: Other: Saline injection group (Consistent with esketamine injection volume) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response rate
Response is defined as two consecutive HAMD-24 scores ≤ 50% before treatment after receiving MECT treatment. The response rate is calculated as the number of patients who achieved as response divided by the total number of patients receiving MECT.In this study, the 24-item version of HAMD was utilized.
Measured: immediately after the end of each MECT procedure
Secondary outcomes (5)
Remission rate of depressive symptoms after MECT treatment
Remission is defined as a sustained HAMD scores below 10 points for two consecutive times. In this study, the 24-item version of HAMD was utilized.The remission rate is calculated as the number of patients who achieved remission divided by the total number of patients receiving MECT.
Measured: immediately after the end of each MECT procedure
Changes in cognitive function
Cognitive function changes were evaluated using the Montreal Cognitive Assessment (MoCA) scales before MECT and at the end of MECT course.
Measured: Immediately after the end of MECT course
The remission rate of suicidal ideation
Suicidal ideation were evaluated using the the Beck Scale for Suicidal Ideation.The remission rate of SI is calculated as the number of patients with SI remission after MECT divided by the total number of patients with SI.
Measured: through treatment completion, an average of 18 days
Changes in psychiatric symptoms
Changes in psychotic symptoms that accompany depression during treatment were assessed using the Positive and Negative Syndrome Scale(PANSS) after each MECT session.
Measured: Immediately after the end of MECT course
Wechsler Memory Scale-Chinese-Revision
The Wechsler Memory Scale-Chinese-Revision(WMS-RC)was used to assess patients'learning and memory functions before and at the end of Modified Electroconvulsive Therapy(MECT).
Measured: Immediately after the end of MECT course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start25 Nov 2025
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Dec 2026 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Su, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Su Min, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247968
- Sponsor's protocol ID
- Esketamine2025-629-01
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data(IPD)is detailed information collected from each study participant.There are several reasons why IPD might not be shared: * Privacy and Confidentiality Concerns * Personal Identifiable Information:IPD contains sensitive information like medical history and genetic data.Sharing it without safeguards can violate privacy and lead to issues like discrimination. * Regulatory Requirements:Laws like GDPR require strict handling of personal data.Sharing IPD without proper anonymization and consent can result in legal problems. * Intellectual Property and Commercial Interests * Research Investment:Generating IPD requires significant resources.Researchers may want to control the data to fully exploit it for further research and publications. * Patent and Licensing Issues:Premature sharing of IPD can affect patentability and licensing agreements. * Data Integrity and Misuse * Quality Control:Shared IPD can be misinterpreted by others who lack context,leading
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Mechanistic Study of Subanesthetic-dose Esketamine in Modified Electroconvulsive Therapy for Adolescents With Severe Depression
- ClinicalTrials.gov ID
- NCT07247968
- Acronym / sponsor ID
- Esketamine2025-629-01
- Conditions
- Esketamine, ECT, Depression, Adolescent
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Min SuUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 25 Nov 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.
The study design was a randomized, double blind, parallel controlled trial.The goal of this clinical trial is to learn if esketamine-assisted modified electroconvulsive therapy (ESK-MECT) works to treat severe depression in adolescents. It will also learn about the safety of ESK-MECT.
The sample size was calculated based on the response rate of patients with depression undergoing electroconvulsive therapy(ECT).According to the results of the pilot study,the efficacy rate of subjects receiving adjunctive esketamine was approximately 78%,while the efficacy rate of those receiving only propofol was 63%.The expected superiority difference in remission rates between the two groups was 15%(one-sided)for the power calculation.Assuming a significance level of α=0.05 and a test power of β=0.2,with a 1:1 ratio of sample sizes between the two groups,the total sample size was calculated to be 198 using the PASS software(PASS 2023).Considering a dropout rate of 10%,a total of 220 subjects were required,with 110 subjects in each group.
- 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 normal saline consistent with esketamine injection volume, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy.
Efficacy evaluation 1. Main efficacy indicators Response rate of depressive symptoms after MECT treatment Response is defined as two consecutive HAMD-24 scores ≤ 50% before treatment after receiving MECT treatment. The response rate is calculated as the number of patients who achieved as response divided by the total number of patients receiving MECT.In this study, the 24-item version of HAMD was utilized.
Participants will:
Be randomly assigned to the esketamine group or the control group, and receive standard MECT treatment.
Have seizure parameters, seizure duration, vital signs, and complications recorded.
Complete psychiatric scale assessments, including HAMD-24, BSS, PANSS, WMS-RC and MoCA.
Be assessed at the following time points: HAMD-24 and BSS after each treatment; PANSS after each treatment course;WMS-RC and MoCA before MECT and after one treatment course.
All subjects did not discontinue antidepressants before modified electroconvulsive therapy(MECT),and they were fasting for 8 hours and no fluids for 2 hours.Three minutes before MECT,continuous qCON monitoring(Apollo-9000A,Chongqing Xideer Medical Equipment Co.,Ltd.,China)was initiated,while monitoring blood pressure,heart rate,and peripheral capillary oxygen saturation.Preoxygenation was administered for 3 minutes.The qCON monitor uses three electrodes on the forehead to collect raw electroencephalogram(EEG)signals.The qCON monitoring includes the qCON index,qNOX index,burst suppression(BS),and signal quality index(SQI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine injection group (0.25mg/kg) | Experimental | Drug: Esketamine injection group (0.25 mg/kg)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 (1.5mg/kg) for 30 s.After the loss of consciousness, all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness. |
| Saline injection group(Consistent with esketamine injection volume) | Sham comparator | Other: Saline injection group (Consistent with esketamine injection volume)The main anesthesiologist standing on the right side of the patient gave successive injections of saline (Consistent with esketamine injection volume), and 1 minute later, injected 1.5mg/kg of propofol in 30s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Inpatients diagnosed with Major Depressive Disorder according to the International Classification of Diseases,11th Revision(ICD-11),and scheduled for Modified Electroconvulsive Therapy(MECT);
- Aged 13 to 17 years,regardless of gender;
- Educational attainment of primary school or higher;
- Normal hearing and vision,including color perception;
- Voluntary participation in the study with signed informed consent;
Key exclusion criteria (7 listed)
- Severe cardiovascular disease,significant arrhythmias,or other cardiac conditions;
- Inability to complete the assessment scales;
- History of substance abuse;
- Received electroconvulsive therapy(ECT)within 6 months prior to the study;
- Severe cerebrovascular disease,severe hypertension,intracranial hypertension,or presence of intracranial electrodes;
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 |
|---|---|---|
| Esketamine injection group (0.25 mg/kg)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.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness. | Drug | Esketamine injection group (0.25mg/kg) |
| Saline injection group (Consistent with esketamine injection volume)The main anesthesiologist standing on the right side of the patient injects saline (Consistent with esketamine injection volume) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness. | Other | Saline injection group(Consistent with esketamine injection volume) |
Primary outcome
Treatment response rate
Time frame: immediately after the end of each MECT procedure
Response is defined as two consecutive HAMD-24 scores ≤ 50% before treatment after receiving MECT treatment. The response rate is calculated as the number of patients who achieved as response divided by the total number of patients receiving MECT.In this study, the 24-item version of HAMD was utilized.
5 secondary outcomes
Remission rate of depressive symptoms after MECT treatment
Time frame: immediately after the end of each MECT procedure
Changes in cognitive function
Time frame: Immediately after the end of MECT course
The remission rate of suicidal ideation
Time frame: through treatment completion, an average of 18 days
Changes in psychiatric symptoms
Time frame: Immediately after the end of MECT course
Wechsler Memory Scale-Chinese-Revision
Time frame: Immediately after the end of MECT course
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 7 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data(IPD)is detailed information collected from each study participant.There are several reasons why IPD might not be shared: * Privacy and Confidentiality Concerns * Personal Identifiable Information:IPD contains sensitive information like medical history and genetic data.Sharing it without safeguards can violate privacy and lead to issues like discrimination. * Regulatory Requirements:Laws like GDPR require strict handling of personal data.Sharing IPD without proper anonymization and consent can result in legal problems. * Intellectual Property and Commercial Interests * Research Investment:Generating IPD requires significant resources.Researchers may want to control the data to fully exploit it for further research and publications. * Patent and Licensing Issues:Premature sharing of IPD can affect patentability and licensing agreements. * Data Integrity and Misuse * Quality Control:Shared IPD can be misinterpreted by others who lack context,leading
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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.
Su Min principal investigator
First Affiliated Hospital of Chongqing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Esketamine injection group (0.25 mg/kg) and Saline injection group (Consistent with esketamine injection volume) in people with Esketamine and ECT, run by Min Su at 2 sites in China.
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 7 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 Xiaoge Han, Master (023-89011061, 3164233689@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response rate (time frame: immediately after the end of each MECT 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 7 Jan 2026.