Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122954
Status:
COMPLETED
Last Update Posted:
2017-06-08
First Post:
2005-07-20
Brief Title:
Fish Oil for the Treatment of Depression in Patients With Multiple Sclerosis
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Fish Oil as an Adjunct Therapy for Depression in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2017-05
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 determine whether fish oil can reduce depression in people with multiple sclerosis MS who are mild to moderately depressed and are currently taking antidepressant medication
Study hypothesis Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale MADRS or Beck Depression Inventory BDI better than placebo
Study hypothesis Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale MADRS or Beck Depression Inventory BDI better than placebo
Detailed Description:
Depression occurs in 50 to 60 of all individuals with MS Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects Therefore fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication
This study will last 3 months Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months At the end of 3 months participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months Participants will do no respond to treatment will be excused from the study All participants will remain on their antidepressants and MS medication throughout the study Participants will have weekly study visits At each visit participants will be asked about their general health and self-report scales will be used to assess depressive symptoms Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis Blood collection will occur at study start and at study completion
This study will last 3 months Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months At the end of 3 months participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months Participants will do no respond to treatment will be excused from the study All participants will remain on their antidepressants and MS medication throughout the study Participants will have weekly study visits At each visit participants will be asked about their general health and self-report scales will be used to assess depressive symptoms Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis Blood collection will occur at study start and at study completion
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 |
|---|---|---|---|
| K23AT002155-01 | NIH | None | httpsreporternihgovquickSearchK23AT002155-01 |