Clinical trial
Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
Name
1stChongqingMUZXY
Description
The aim of this project is to investigate the multimodal magnetic resonance brain imaging changes in adolescents with major depressive disorder (MDD) before and after electroconvulsive therapy. Development of a predictive model for the efficacy of electroconvulsive therapy in adolescent MDD.
Trial arms
Trial start
2023-11-06
Estimated PCD
2024-12-31
Trial end
2026-01-01
Status
Recruiting
Treatment
Modified Electroconvulsive Therapy
MECT is performed using the Thymatron System IV (Somatics LLC, LakeBluff, IL, USA) electroconvulsive therapy (ECT) machine. Prior to ECT, all patients undergo laboratory tests such as routine blood, liver, kidney and thyroid function and an ECG and remain fasted for 12 hours. Initial treatment power is considered by age: percentage of power = age x 0.7. Stimulation power is adjusted according to seizure duration. If the seizure duration is less than 25 seconds, the energy is increased by 5% in the subsequent treatments. Anaesthesia and muscle relaxation were administered with propofol (1.5-2 mg/kg) and succinylcholine (0.5-1 mg/kg), respectively, and subjects were awakened after ECT treatment and adverse effects, such as subjective memory impairment, headache or nausea/vomiting, were recorded. Frequency of ECT treatment: 3-4 times per week for a total of 6-8 sessions
Arms:
Modified electroconvulsive therapy group
Conventional pharmacotherapy
Conventional pharmacotherapy: SSRIs including fluoxetine, paroxetine, sertraline, cetinopram, fluvoxamine, vortioxetine, escitalopram; SNRIs including venlafaxine, duloxetine; NaSSA including mirtazapine; other antidepressants including trazodone, bupropion, agomelatine; potentiators including aripiprazole, olanzapine, quetiapine, risperidone.
Arms:
Modified electroconvulsive therapy group, Non-modified electroconvulsive therapy group
Size
180
Primary endpoint
Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores
The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Eligibility criteria
Inclusion criteria for the modified electroconvulsive therapy (MECT) and non-modified electroconvulsive therapy (Non-MECT) groups:
1. Age 13-18 years.
2. Meeting a diagnosis of depression (MDD) from the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) based the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
3. A score of ≥40 on the Childhood Depression Rating Scale-Revised (CDRS-R).
4. Adequate audiovisual level to be able to complete this study.
5. Signed informed consent and signed by the subject and guardian.
Healthy control group inclusion criteria.
1. Age 13-18 years.
2. Sufficient audio-visual level to be able to complete the study.
3. Signed informed consent form and signed by the subject and guardian.
Exclusion criteria for the modified electroconvulsive therapy (MECT) and non-modified electroconvulsive therapy (Non-MECT) groups:
1. The presence or previous presence of a serious medical, neurological or psychiatric condition (except in patients with MDD; anxiety co-morbidity is not considered an exclusion criterion, provided that MDD is the primary diagnosis and the main reason for seeking life-saving treatment).
2. Patients who have received electroconvulsive therapy within the last 12 months.
3. Patients with a history of substance, drug abuse.
4. Contraindications to anaesthesia or MRI.
5. Lactating women or pregnant women.
6. Left-handedness.
Exclusion criteria for healthy controls:
1. Presence or previous serious medical, neurological or psychiatric illness.
2. Patients with a history of substance or drug abuse.
3. Contraindications to MRI.
4. Lactating women or pregnant women.
5. Left-handedness.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}
Updated at
2023-09-28
1 organization
1 product
3 indications
Product
Conventional pharmacotherapyIndication
Major Depressive DisorderIndication
Magnetic Resonance ImagingIndication
Electroconvulsive therapy