Clinical trial NCT05889234: Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
Official title: Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Magnetic Resonance Imaging
Electroconvulsive Therapy
Keywords: adolescent MDD
MECT
Multimodal MRI
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Chongqing Medical University
name: Second Xiangya Hospital of Central South University
First posted: 2023-06-05
Enrollment: 180
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

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.

Primary outcomes:
measure: Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores
timeFrame: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Secondary outcomes:
measure: Changes in BDI (Beck's Depression Inventory) scores
timeFrame: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
measure: Changes in SCARED (Screen for Child Anxiety Related Disorders) scores
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in suicide risk on C-SSRS (Columbia Suicide Severity Rating Scale) scores
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in PSQI (Pittsburgh Sleep Quality Index) scores
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in CGI-S (Clinical Global Impressions-Severity Scales) scores
timeFrame: Baseline of treatment period, 2-4 weeks
measure: Changes in CGI-I (Clinical Global Impressions-Improvement Scales) scores
timeFrame: The treatment period was 2-4 weeks
measure: Changes in RSS (Ruminative Responses Scale) scores
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Assessment of CTQ（Childhood Trauma Questionnaire）
timeFrame: Baseline of treatment period
measure: Assessment of OB/VQ（Olweus Bully/Victim Questionnaire）
timeFrame: Baseline of treatment period
measure: Changes in AE（Adverse Event）Scale
timeFrame: The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.
measure: Assessment of SAE（Serious Adverse Event）Scale
timeFrame: The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.
measure: Changes in THINC-it
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in functional MRI
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in structural MRI T1 and T2
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in Cerebral Blood Flow
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
measure: Changes in concentration of Glu and GABA in ACC
timeFrame: Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Province
Study officials:
References: