Omacor for Perimenopausal Depression - Full Text View

Sponsors and Collaborators:	University of Arizona Reliant Pharmaceuticals
Information provided by:	University of Arizona
ClinicalTrials.gov Identifier:	NCT00517972

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: Omacor (omega-3-acid ethyl esters)	Phase II

MedlinePlus related topics: Depression

Drug Information available for: Omacor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Omacor for Perimenopausal Depression

Further study details as provided by University of Arizona:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Decrease in the Greene Climacteric Scale by 50%.

Estimated Enrollment:	20
Study Start Date:	March 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517972

Contacts

Contact: Marlene P Freeman, M.D.

520-626-6509

marlenef@email.arizona.edu

Locations

United States, Arizona
Women's Mental Health Program; University of Arizona	Recruiting
Tucson, Arizona, United States, 85724
Contact: Marlene P Freeman, M.D. 520-626-6509 marlenef@email.arizona.edu
Principal Investigator: Marlene P Freeman, M.D.

Sponsors and Collaborators

University of Arizona

Reliant Pharmaceuticals

Investigators

Principal Investigator:

Marlene P Freeman, M.D.

University of Arizona

More Information

Study ID Numbers:	HSC#06-102;IND76801
Study First Received:	August 15, 2007
Last Updated:	August 15, 2007
ClinicalTrials.gov Identifier:	NCT00517972
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arizona:

perimenopausal depression
omacor
major depressive disorder
women

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009