Omacor for Perimenopausal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517972
Recruitment Status : Withdrawn
First Posted : August 17, 2007
Last Update Posted : March 29, 2012
Reliant Pharmaceuticals
Information provided by:
University of Arizona

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Drug: Omacor (omega-3-acid ethyl esters) Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omacor for Perimenopausal Depression

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction of the initial HAM-D score by 50% or more at week 8 of the trial.
  2. Reduction of the HAM-D score to less than 7 at week 8.
  3. Clinical Global Impression change in score achievement to "very much improved" or "much improved" at week 8.

Secondary Outcome Measures :
  1. Decrease in the Greene Climacteric Scale by 50%.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517972

United States, Arizona
Women's Mental Health Program; University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Reliant Pharmaceuticals
Principal Investigator: Marlene P Freeman, M.D. University of Arizona Identifier: NCT00517972     History of Changes
Other Study ID Numbers: HSC#06-102;IND76801
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by University of Arizona:
perimenopausal depression
major depressive disorder

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders