Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders

United States Department of Defense

Status and phase: Unknown; Phase 2

Conditions: Combat Disorders; Depression; Mood Disorders; Stress Disorders

Treatments: Drug: Placebo, visually identical to Lovaza; Drug: Lovaza, omega-3 fatty acid ethyl ester

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01216982

M-10023

Details and patient eligibility

About

Stress-related disorders are among the most prevalent and expensive medical consequences of participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are known to benefit both neuronal development in the young, and cognition and mood in various populations.

It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher cognitive performance, better affect/mood state, and less combat stress symptomatology compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the prevalence of combat stress injuries in military personnel.

Enrollment: 256 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• US Army deployed personnel
• score on a mood questionnaire

Exclusion criteria

• currently consume omega-3 fish oil supplements
• are currently taking antidepressant or other medications for psychiatric purposes
• pregnant
• known fish or shellfish allergy

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 2 patient groups, including a placebo group

Lovaza, omega-3 fatty acid ethyl ester

Active Comparator group

Treatment:

Drug: Lovaza, omega-3 fatty acid ethyl ester

Placebo

Placebo Comparator group

Description:

one gram corn oil in a soft gelatin capsule

Treatment:

Drug: Placebo, visually identical to Lovaza