Omacor for Perimenopausal Depression

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Collaborator: Reliant Pharmaceuticals

Criteria

Inclusion Criteria:

• Women age 40 years old or older.

• Subjects must have perimenopausal symptoms of at least 3 months duration, and which include irregular periods and/or hot flashes.

• Subjects must have a minimum score of 15 on the Hamilton Rating Scale for Depression.

• Subjects must be willing to be treated on an outpatient basis.

• Subjects must provide written informed consent.

Exclusion Criteria:

• Subjects presently taking antidepressant medication.

• Subjects currently using hormone replacement therapy (HRT).

• Subjects currently taking omega-3 fatty acid supplements.

• Presence of psychotic symptoms.

• History of mania or hypomania.

• Hamilton Rating Scale for Depression (HAM-D) suicide item score > 3.

• Abnormal uterine bleeding (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods) that has not been evaluated by a gynecologist.