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

Overview

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.

Full Title of Study: “Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2011

Interventions

  • Drug: Lovaza, omega-3 fatty acid ethyl ester
    • Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
  • Drug: Placebo, visually identical to Lovaza
    • Three 1g corn oil capsules/day for three months

Arms, Groups and Cohorts

  • Active Comparator: Lovaza, omega-3 fatty acid ethyl ester
  • Placebo Comparator: Placebo
    • one gram corn oil in a soft gelatin capsule

Clinical Trial Outcome Measures

Primary Measures

  • primary psychometric assessment battery
    • Time Frame: 3 months
    • Specific components include: Zung Depression Scale (ZDS) Zung Anxiety Scale (ZAS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)
  • omega-3 fatty acid status
    • Time Frame: 3 months
    • finger-prick blood spot is collected for determination of fatty acid composition and profile.

Secondary Measures

  • secondary psychometric assessment battery
    • Time Frame: 3 months
    • This battery will generate index scores in the area of: Memory, Psychomotor Speed, Reaction Time, Cognitive Flexibility, and Complex Attention. It will also include the Alcohol Use Identification Test (AUdIT). Military-specific components include Post-Deployment Health Assessment (PDHA), Neurobehavioral Symptom Inventory (NSI), Combat Exposure Scale (CES), and parts of the Deployment Risk and Resilience Inventory (edited).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • United States Department of Defense
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Daniel T. Johnston, MD, MPH, LTC, US Army MC,, 1st CAB, US ARMY
  • Overall Official(s)
    • Daniel T Johnston, MD, MPH, Principal Investigator, United States Department of Defense

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.