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
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT05145270
- Lead Sponsor
- Shanghai Mental Health Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Escitalopram plus Sulforaphane Escitalopram+Sulforaphane The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. The oral dose of SFN is based on weight. The usage and dosage are as follows: 40-70kg, 4 tablets/day (containing 274μmol of glucosinolates); 70-90kg, 6 tablets/day (containing 411μmol of glucosinolates). Take it once in the morning and evening. Escitalopram plus rTMS Escitalopram+rTMS The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. 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. Escitalopram Escitalopram The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. Escitalopram plus Sulforaphane Escitalopram The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. The oral dose of SFN is based on weight. The usage and dosage are as follows: 40-70kg, 4 tablets/day (containing 274μmol of glucosinolates); 70-90kg, 6 tablets/day (containing 411μmol of glucosinolates). Take it once in the morning and evening. Escitalopram plus rTMS Escitalopram The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. 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.
- Primary Outcome Measures
Name Time Method the reduction rate in 17-HDRS total score from baseline to the end of the study at baseline, week 2/4/8/12 after treatment. Remission is defined as 17-HDRS total score ≤7; Response is defined as ≥50% decrease from 17-HDRS total score at baseline and 17-HDRS total score\>7; Nonresponse is defined as having a reduction of\<50% on the total score of 17-HDRS comparing with baseline.
- Secondary Outcome Measures
Name Time Method changes in levels of serum markers from baseline to the end of the study at baseline, week 8-12 after treatment. changes in levels of serum markers including nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, malondialdehyde (MDA), superoxide dismutase (SOD) and erythrocyte glutathion peroxidase (GPX)
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, China
Shanghai Mental Health Center🇨🇳Shanghai, ChinaYifeng Shen, Ph.DContact8621-34773657shenyifeng@yahoo.com