Omacor for Perimenopausal Depression
Recently, antidepressants and other similar acting agents have been explored as a class of medications to treat major depressive disorder (MDD) in the context of perimenopause, as well as the somatic symptoms of perimenopause (such as hot flashes). Omega-3 fatty acids, which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are nutritional compounds with widely established health benefits and which occur naturally in fish and marine sources. Results of previous mood disorder studies have indicated that omega-3 fatty acids may be of help in the treatment of depression. Therefore, the current study is designed to examine the effectiveness and tolerability of the study drug, Omacor, (omega-3 fatty acid ethyl esters), in the treatment of major depressive disorder in perimenopausal women.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Omacor for Perimenopausal Depression|
- Reduction of the initial HAM-D score by 50% or more at week 8 of the trial.
- Reduction of the HAM-D score to less than 7 at week 8.
- Clinical Global Impression change in score achievement to "very much improved" or "much improved" at week 8.
- Decrease in the Greene Climacteric Scale by 50%.
|United States, Arizona|
|Women's Mental Health Program; University of Arizona|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||Marlene P Freeman, M.D.||University of Arizona|