NCT05047159

The Role of Neuromodulation Technique In Depression Disorder

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy, safety and long-term effects of common and available non-invasive neuromodulation techniques in the treatment of depression, and to provide a data basis for the establishment of individualized treatment and efficacy prediction models. 450 patients will be enrolled and randomly assigned to five different treatments. Psychopathological assessment will be performed in both acute and maintenance phases of treatment with the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Patient Health Questionaire-9, the Sheehan Disability Scale, the Vascular Quality of Life-6 Questionnaire respectively.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	rTMS	Stimulation will be performed for 20 working days once a day (4 weeks). Extend course to 30 sessions (6 weeks) in responders who have not achieved symptom remission. Frequency: 10Hz; Intensity: 110% RMT; Coil-type: F8; Sessions-pulse: 3000; Site: the left dorsolateral prefrontal cortex.
DEVICE	light therapy	Active 10,000-lux fluorescent white light box for 30 min/d in the early morning for 6 weeks.
DEVICE	ECT	The electrode placements are bifrontal (BF); the electrical intensity is 1.5 to 2.0 times the seizure threshold (ST); 3 times per week.
DEVICE	MST	A coil placement at the vertex (i.e., Cz in 10-20 electroencephalogram \[EEG\] system) with a frequency of stimulation of 100 Hz, pulse width of 0.2 to 0.4 ms, and stimulation duration of 10 seconds; 2 times per week.
DRUG	drug therapy	There is no restriction on the choice of therapeutic drugs.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-03-30
• Completion: 2024-06-30
• First posted: 2021-09-16
• Last updated: 2022-10-27

Locations

1 site across 1 country: China