Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05148169
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-12-02
Brief Title:
A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder
Sponsor:
Shanghai Mental Health Center
Organization:
Shanghai Mental Health Center
Study Overview
Official Title:
A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder
Status:
UNKNOWN
Status Verified Date:
2021-11
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 will be conducted to explore the effect of add-on sulforaphane SFN to selective serotonin reuptake inhibitors SSRIs for major depressive disorder MDD This study also aims to explore the value of niacin skin flush response test in MDD One hundred adults diagnosed with MDD will be recruited Then all the patients will be randomly assigned to SSRI only group and SSRI plus SFN group Clinical symptoms and side-effects will be evaluated using the 17-Hamilton Depression Rating Scale 17-HDRS the Hamilton Anxiety Scale HAMA Treatment Emergent Symptom Scale TESS and Asbergs Rating Scale for Side Effects SERS at baseline and weeks 2 4 8 and 12 after treatment Fifty healthy subjects will be recruited as control group For all subjects testing of niacin skin flush response and serum levels of nuclear factor erythroid-2-related factor 2Nrf-2 p-Nrf2 Heme Oxygenase-1 HO-1 malondialdehyde MDA and erythrocyte glutathion peroxidase GPX will be performed 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