NCT05145270

A Comparative Study on Efficacy and Safety of add-on Sulforaphane or rTMS to Escitalopram for Major Depressive Disorder With Poor Response to Initial Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A 12-week, randomized controlled trial (RCT) with parallel grouping design will be conducted to compare the efficacy and safety of different treatments. One hundred and eighty adults diagnosed with major depressive disorder (MDD) with no or poor response to initial antidepressant treatment will be recruited. Then all the patients will be 1:2:2 randomly assigned to different intervention groups including escitalopram, escitalopram plus sulforaphane (SFN) , and escitalopram plus repetitive transcranial magnetic stimulation (rTMS). Clinical symptoms and side-effects will be evaluated or recorded using the 17-Hamilton Depression Rating Scale (17-HDRS), the Hamilton Anxiety Scale (HAMA), side-effects sheet, etc., at Critical Decision Points (CDP) including weeks 2, 4, 8 and 12 after treatment. Blood cell counting, biochemical, and electrocardiogram examination will be performed at weeks 4, 8 and 12 after treatment in order to evaluate the effect of different interventions on the physical condition. In addition, niacin skin flush response and serum markers including nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, malondialdehyde (MDA), superoxide dismutase (SOD) and erythrocyte glutathion peroxidase (GPX) will be tested at baseline and endpoint. The primary outcome is the reduction rate in 17-HDRS total score from baseline to the end of the study. The secondary outcomes include changes in niacin skin flush response test and levels of serum markers. All the data will be analyzed by SPSS software.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Escitalopram+Sulforaphane	Escitalopram(No-specified) 10-20mg/d, once per day; Sulforaphane(ZHIYINGUOSU, Shenzhen Fushan Biotech Co. Ltd.). 40-70kg, 4 tablets/day (containing 274μmol of glucosinolates); 70-90kg, 6 tablets/day .
DEVICE	Escitalopram+rTMS	Escitalopram(No-specified) 10-20mg/d, once per day; rTMS: rTMS is delivered to the left dorsolateral prefrontal lobe position. Stimulation parameters are set to be 80 stimulation strings of 10Hz with an interval of 12 seconds. Each stimulation string includes 30 stimulations lasting for 3 seconds. One session includes 2400 stimulation strings lasting for 19 minutes and 40 seconds. The course of rTMS treatment includes 20 sessions, once a day or twice a day.
DRUG	Escitalopram	Escitalopram(No-specified) 10-20mg/d, once per day.

Timeline

• Start date: 2019-11-30
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2021-12-06
• Last updated: 2021-12-06

Locations

1 site across 1 country: China