Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder; Sulforaphane; rTMS; Efficacy; Oxidative stress; Marker; Add-on
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.
Interventions
DIETARY_SUPPLEMENTEscitalopram+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 .
DEVICEEscitalopram+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.
DRUGEscitalopram
Escitalopram(No-specified) 10-20mg/d, once per day.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
All the participants 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria are as follows: 1. aged 18-60 years; 2. diagnosed with moderate or severe depressive disorder according to the criteria of the DSM-5; 3. total score of 17-HDRS≥17; 4. never receiving electroconvulsive therapy (ECT)/modified ECT (MECT)/rTMS or other treatments in the past month; 5. no response or poor response (having a reduction of \<20% on the total score of the 17-item Hamilton Depression Scale compared with the baseline) to adequate antidepressants (except escitalopram) treatment for at least 4 weeks; 6. having sufficient audio-visual ability and comprehension; 7. signed informed consent statements. The
Exclusion criteria
are as follows: 1. serious or active somatic illness (abnormal index values were more than twice the limit of normal); 2. a history of mania/hypomania; 3. current high risk of suicide (score of item 3 of 17-HDRS ≥ 3); 4. pregnant or lactating women, or planning pregnant women; 5. taking immunosuppressants or vitamins recently.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactXiaohua Liu, Dr.
Outcome results
None listed