Ignite Creation Date:
2024-05-05 @ 9:53 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00981383
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2009-09-10
Brief Title:
Treating Depression in Coronary Artery Disease With Omega-3 Fatty Acids
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
CAROTID CAD Randomized Omega-3 Trial In Depression
Status:
COMPLETED
Status Verified Date:
2017-04
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:
CAROTID
Brief Summary:
Depressive disorders are common in patients with Coronary Artery Disease CAD occurring in up to 47 of patients Left untreated these symptoms not only have a strong negative impact on quality-of-life but also increase risk of future cardiac events and death Unfortunately about 64 of CAD patients do not respond to current antidepressant treatments Eicosapentaenoic acid EPA and docosahexaenoic acid DHA are two omega-3 ω-3 fatty acids found in fatty fish that are important for brain function Recent evidence showed that depressed CAD patients have lower levels of EPA and DHA than non-depressed CAD patients This information taken together with the known roles of ω-3 fatty acids in brain function suggests that deficiencies may contribute to depression However it is unknown if increasing consumption of ω-3 fatty acids would alleviate depression and improve quality of life While intake of adequate levels of ω-3 fatty acids is difficult to obtain through diet concentrated supplements containing EPA and DHA that are safe readily available and inexpensive are now obtainable in Canada CAROTID CAD Randomized Omega-3 Trial In Depression will randomize patients with CAD with and without depressive symptoms after 6 months of cardiac rehabilitation and usual care to receive either ω-3 fatty acid supplements or placebo daily during their final 6 months of cardiac rehabilitation The investigators hypothesize that CAD patients randomized to receive ω-3 fatty acid supplements will show greater improvement in depressive symptoms and quality-of-life over time The investigators will also evaluate possible improvements in other important determinants of quality of life memory and other cognitive abilities
Detailed Description:
Coronary artery disease CAD poses a serious risk to the health and well-being of the elderly Depression is common among CAD patients and has a major negative impact on treatment outcomes and life expectancy Late-life depression is also associated with symptoms of cognitive impairment and subsequent nonresponse to medications Coronary artery disease and depression together can detrimentally affect autonomous seniors resulting in increased caregiver dependence and health care resource use
Forty-seven percent of patients with CAD have depressive disorders About 64 of these do not respond to antidepressant treatments Recent evidence shows that depressed CAD patients have lower levels of omega-3 fatty acids than do non-depressed CAD patients Along with the known role of omega-3 fatty acids in brain health this suggests that deficiencies may affect depression
Our study CAROTID CAD Randomized Omega-3 Trial In Depression is a randomized double-blind placebo-controlled parallel group trial in persons with CAD who are attending a cardiac rehabilitation program Patients will receive either omega-3 fatty acids supplements or placebo daily during three months of cardiac rehab We hypothesize that patients who receive omega-3 fatty acids will show greater improvements in depressive symptoms and quality of life This research will determine whether there is an antidepressant effect of omega-3 fatty acids in CAD patients undergoing cardiac rehabilitation If successful then CAROTID will provide evidence to guide health care providers in the recommendation and use of these supplements
Forty-seven percent of patients with CAD have depressive disorders About 64 of these do not respond to antidepressant treatments Recent evidence shows that depressed CAD patients have lower levels of omega-3 fatty acids than do non-depressed CAD patients Along with the known role of omega-3 fatty acids in brain health this suggests that deficiencies may affect depression
Our study CAROTID CAD Randomized Omega-3 Trial In Depression is a randomized double-blind placebo-controlled parallel group trial in persons with CAD who are attending a cardiac rehabilitation program Patients will receive either omega-3 fatty acids supplements or placebo daily during three months of cardiac rehab We hypothesize that patients who receive omega-3 fatty acids will show greater improvements in depressive symptoms and quality of life This research will determine whether there is an antidepressant effect of omega-3 fatty acids in CAD patients undergoing cardiac rehabilitation If successful then CAROTID will provide evidence to guide health care providers in the recommendation and use of these supplements
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