Omacor for Perimenopausal Depression

NCT00517972 | Withdrawn Phase 2

• 1 other identifier: HSC#06-102;IND76801
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

perimenopausal depression; omacor; major depressive disorder; women

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Decrease in the Greene Climacteric Scale by 50%.

Interventions

Omacor (omega-3-acid ethyl esters) DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Reliant Pharmaceuticals: collaborator

Study Sites (1)

Women's Mental Health Program; University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Omacor

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Marlene P Freeman, M.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 17, 2007
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

US (1)