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

Chongqing Medical University

Status: Enrolling

Conditions: Major Depressive Disorder; Electroconvulsive Therapy; Magnetic Resonance Imaging

Treatments: Device: Modified Electroconvulsive Therapy; Drug: Conventional pharmacotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05889234

1stChongqingMUZXY

Details and patient eligibility

About

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.

Full description

This is a multicenter, prospective, observational study. We will divide the adolescent MDD patients into two groups according to the treatment modality as follows: Group 1 (Modified Electroconvulsive Therapy (MECT), n=60); Group 2 (Non-Modified Electroconvulsive Therapy (Non-MECT), n=60). Patients in group 1 will be treated with MECT according to standard clinical care. Group 2 will receive conventional drug therapy. A healthy control group (n=60) will also be recruited.

The most modern MRI sequences examining brain structure and function are used at 4 time points: at baseline (just before MECT series), the second examination (just after MECT series) and the third and forth (follow-up) examination (3 and 6 months after MECT series). Blood, urine and feces samples and the evaluation of clinical effect and side-effects to MECT are performed at the same time points.

The primary outcome for the treatment phase is the treatment remission rate and response rate. The secondary outcomes included: symptom scale, Quality of life, Sleep therapy, Symptoms of anxiety, Rumination and safety assessment.

Enrollment: 180 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

180 participants in 3 patient groups

Modified electroconvulsive therapy group

Description:

The adolescent MDD receiving modified electroconvulsive therapy and conventional medication.

Treatment:

Drug: Conventional pharmacotherapy

Device: Modified Electroconvulsive Therapy

Non-modified electroconvulsive therapy group

Description:

The adolescent MDD receiving only conventional medication.

Treatment:

Drug: Conventional pharmacotherapy

Healthy controls group

Description:

Healthy adolescents.