Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study

NCT05889234 | Unknown DMC

• 1 other identifier: 1stChongqingMUZXY
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Magnetic Resonance Imaging; Electroconvulsive Therapy

Keywords

adolescent MDD; MECT; Multimodal MRI

Outcome Measures

Primary Outcomes (1)

• Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores

  Clinical response (≥ 50% reduction in CDRS-R scores from baseline).

  The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.

Secondary Outcomes (17)

• Changes in BDI (Beck's Depression Inventory) scores

  The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.

• Changes in SCARED (Screen for Child Anxiety Related Disorders) scores

  Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months

• Changes in suicide risk on C-SSRS (Columbia Suicide Severity Rating Scale) scores

  Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months

• Changes in PSQI (Pittsburgh Sleep Quality Index) scores

  Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months

• Changes in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores

  Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months

Study Arms (3)

Modified electroconvulsive therapy group

The adolescent MDD receiving modified electroconvulsive therapy and conventional medication.

Device: Modified Electroconvulsive Therapy; Drug: Conventional pharmacotherapy

Non-modified electroconvulsive therapy group

The adolescent MDD receiving only conventional medication.

Drug: Conventional pharmacotherapy

Healthy controls group

Healthy adolescents.

Interventions

Modified Electroconvulsive Therapy DEVICE

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

Modified electroconvulsive therapy group

Conventional pharmacotherapy DRUG

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.

Modified electroconvulsive therapy group; Non-modified electroconvulsive therapy group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients accepted for ECT or medication treatment in the inpatient adolescent MDD patients. According to treatment modality in two groups, as follows: Group 1 (modified electroconvulsive therapy (MECT) ,n=60); Group 2 (Non-modified electroconvulsive therapy(Non-MECT), n=60). Each enrolled participant in group 1 will undergo an index course of MECT, following standard clinical care. Group 2 will receive conventional drug therapy. At the same time, a healthy control group (n=60) will be recruited.

You may qualify if:

• Age 13-18 years.
• 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).
• A score of ≥40 on the Childhood Depression Rating Scale-Revised (CDRS-R).
• Adequate audiovisual level to be able to complete this study.
• Signed informed consent and signed by the subject and guardian.
• Age 13-18 years.
• Sufficient audio-visual level to be able to complete the study.
• Signed informed consent form and signed by the subject and guardian.

You may not qualify if:

• Patients who have received electroconvulsive therapy within the last 12 months.
• Patients with a history of substance, drug abuse.
• Contraindications to anaesthesia or MRI.
• Lactating women or pregnant women.
• Left-handedness.
• Presence or previous serious medical, neurological or psychiatric illness.
• Patients with a history of substance or drug abuse.
• Contraindications to MRI.
• Lactating women or pregnant women.
• Left-handedness.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator
• Second Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Province, 400000, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Xinyu Zhou

CONTACT

15823996993; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 5, 2023
• Study Start: November 6, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2026
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)