Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05145270
Status:
UNKNOWN
Last Update Posted:
2021-12-06
First Post:
2021-12-02
Brief Title:
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
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
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
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 122 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 2Nrf-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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None