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Omacor for Perimenopausal Depression

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00517972
First received: August 15, 2007
Last updated: March 27, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
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

Resource links provided by NLM:


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%.

Enrollment: 0
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Women's Mental Health Program; University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Reliant Pharmaceuticals
Investigators
Principal Investigator: Marlene P Freeman, M.D. University of Arizona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00517972     History of Changes
Other Study ID Numbers: HSC#06-102;IND76801
Study First Received: August 15, 2007
Last Updated: March 27, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 27, 2014