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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.
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.
Age
13 - 18 years
Sex
ALL
Healthy Volunteers
Yes
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Province, China
Start Date
November 6, 2023
Primary Completion Date
December 31, 2024
Completion Date
January 1, 2026
Last Updated
September 28, 2023
180
ESTIMATED participants
Modified Electroconvulsive Therapy
DEVICE
Conventional pharmacotherapy
DRUG
Lead Sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborators
NCT07115329
NCT06793397
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07025720