NCT05889234

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: First Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Major Depressive Disorder
• Magnetic Resonance Imaging
• Electroconvulsive Therapy

Interventions

Type	Name	Description
DEVICE	Modified Electroconvulsive Therapy	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
DRUG	Conventional pharmacotherapy	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.

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-12-31
• Completion: 2026-01-01
• First posted: 2023-06-05
• Last updated: 2023-09-28

Locations

1 site across 1 country: China