Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101452
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2005-01-10
Brief Title:
Safety and Effectiveness of S-adenosyl-l-methionine SAMe for the Treatment of Major Depression
Sponsor:
Maurizio Fava MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine SAMe vs Escitalopram in 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:
None
Brief Summary:
The purpose of this study is to determine the safety and effectiveness of s-adenosyl-l-methionine SAMe in treating major depression
Detailed Description:
SAMe is a substance that is naturally produced by the body and is also sold as an over-the-counter drug Although SAMe has not yet been approved for treating depression evidence suggests that it has antidepressant properties This study will determine whether SAMe is safe and effective in treating major depression
This study will last 24 weeks Participants will be randomly assigned to receive either the antidepressant escitalopram SAMe or placebo for 12 weeks Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks Depression scales and self-report questionnaires will be used to assess participants All participants will receive 3 months of follow-up care including free medication and clinic visits as necessary
This study will last 24 weeks Participants will be randomly assigned to receive either the antidepressant escitalopram SAMe or placebo for 12 weeks Participants who respond to treatment at the end of 12 weeks will stay on their regimen for an additional 12 weeks Participants who do not respond to treatment will enter an open treatment phase where they will receive SAMe and escitalopram for 12 more weeks Depression scales and self-report questionnaires will be used to assess participants All participants will receive 3 months of follow-up care including free medication and clinic visits as necessary
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AT001638-01A1 | NIH | None | httpsreporternihgovquickSearchR01AT001638-01A1 |