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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after the end of each MECT procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately after the end of each MECT procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoge Han, Master | Contact | 023-89011061 | 3164233689@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Su Min | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
Individual participant data(IPD)is detailed information collected from each study participant.There are several reasons why IPD might not be shared:
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| 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. |
|
| 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. | 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. | 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. | 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). | Immediately after the end of MECT course |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | China |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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