Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
- Conditions
- Magnetic Resonance ImagingMajor Depressive DisorderElectroconvulsive Therapy
- Interventions
- Drug: Conventional pharmacotherapyDevice: Modified Electroconvulsive Therapy
- Registration Number
- NCT05889234
- Lead Sponsor
- First Affiliated Hospital of Chongqing Medical University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-modified electroconvulsive therapy group Conventional pharmacotherapy The adolescent MDD receiving only conventional medication. Modified electroconvulsive therapy group Modified Electroconvulsive Therapy The adolescent MDD receiving modified electroconvulsive therapy and conventional medication. Modified electroconvulsive therapy group Conventional pharmacotherapy The adolescent MDD receiving modified electroconvulsive therapy and conventional medication.
- Primary Outcome Measures
Name Time Method 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. Clinical response (≥ 50% reduction in CDRS-R scores from baseline).
- Secondary Outcome Measures
Name Time Method 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. The severity of depression symptom.
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 The severity of the suicide risk.
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 The severity of Anxiety symptom.
Changes in PSQI (Pittsburgh Sleep Quality Index) scores Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months Measures of sleep status.
Changes in functional MRI Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months Resting state MRI, measurement of functional connectivity.
Changes in CGI-S (Clinical Global Impressions-Severity Scales) scores Baseline of treatment period, 2-4 weeks Measures of clinical impression severity.
Changes in CGI-I (Clinical Global Impressions-Improvement Scales) scores The treatment period was 2-4 weeks Measures of clinical general Impression scale.
Changes in AE（Adverse Event）Scale The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months. Measures of any untoward medical orrurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Changes in Cerebral Blood Flow Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months Estimated by Arterial Spin Labeling MRI.
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 Measures of children's quality of life.
Assessment of CTQ（Childhood Trauma Questionnaire） Baseline of treatment period Measures of childhood trauma.
Changes in RSS (Ruminative Responses Scale) scores Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months Measures of negative thinking.
Assessment of OB/VQ（Olweus Bully/Victim Questionnaire） Baseline of treatment period Measures of bully/victim problems.
Assessment of SAE（Serious Adverse Event）Scale The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months. Measures of adverse medical events.
Changes in THINC-it Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months Measures of cognition function.
Changes in structural MRI T1 and T2 Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months Measures of brain structure.
Changes in concentration of Glu and GABA in ACC Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months MR Spectroscopy og the ACC, measures of neuronal integrity.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Province, China