Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070941
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2003-10-09
Brief Title:
SAM-e for the Treatment of Depression in Patients With Parkinsons Disease
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
SAM-e Treatment of Depression in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2016-06
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:
This study will test a chemical called s-adenosyl-methionine SAM-e for the treatment of depression in patients with Parkinsons disease PD
Detailed Description:
PD is commonly associated with depression but conventional antidepressants have limited efficacy in patients with PD and may exacerbate motor symptoms SAM-e is available in the United States as a food supplement and is promoted as a mood enhancer SAM-e improves dopamine transmission may have a beneficial effect on dopamine receptors and may be a good alternative to the currently-used antidepressants in patients with PD This study will investigate whether SAM-e is safe and effective in the treatment of depression associated with PD The efficacy of SAM-e will be compared to placebo and to escitalopram a selective serotonin reuptake inhibitor commonly used for the treatment of depression in PD
Participants in this study will be randomly assigned to receive SAM-e escitalopram or placebo for 12 weeks Some participants may choose to extend treatment for an additional 12 weeks for a total of 24 weeks on study medication Participants will have study visits at entry and Weeks 2 4 8 and 12 Study visits will include neurological evaluation psychiatric evaluation blood tests and quality of life questionnaires A telephone interview will be conducted at Week 10
Participants in this study will be randomly assigned to receive SAM-e escitalopram or placebo for 12 weeks Some participants may choose to extend treatment for an additional 12 weeks for a total of 24 weeks on study medication Participants will have study visits at entry and Weeks 2 4 8 and 12 Study visits will include neurological evaluation psychiatric evaluation blood tests and quality of life questionnaires A telephone interview will be conducted at Week 10
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 |
|---|---|---|---|
| R01AT000941-01A1 | NIH | None | None |
| 075255364 | OTHER_GRANT | NIH | httpsreporternihgovquickSearchR01AT000941-01A1 |