Ignite Creation Date:
2024-05-05 @ 9:45 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00955955
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2009-07-30
Brief Title:
Study of 6S-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
Sponsor:
George I Papakostas
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
TRD - 2 A Double-Blind Placebo Controlled Study of 6S-5-MTHF Among SSRI-Resistant Outpatients With Major Depressive Disorder MDD
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
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:
TRD-2
Brief Summary:
The purpose of the study is to test whether oral 6S-5-MTHF Deplin is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors SSRIs
Detailed Description:
The study consists of two phases each lasting a total of four weeks 8 weeks total with visits at the DCRP every 10 days If the subject is eligible they will be asked to return two weeks later for a baseline visit when they will be randomly assigned like a flip of a coin to one of three treatment groups a drugdrug b placebodrug c placeboplacebo a placebo is a pill that looks like a study drug but contains no active medication They will have a greater than 50 chance of receiving active medication Deplin at some point in the 8 week study
Neither the subject nor the research staff will know which group the subject is in
All subjects will be asked to take the study medication in the morning in addition to their ongoing SSRI treatment
Neither the subject nor the research staff will know which group the subject is in
All subjects will be asked to take the study medication in the morning in addition to their ongoing SSRI treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None