Combat Disorders, Depression, Mood Disorders, Stress Disorders
Conditions
Keywords
Mood Disorders, Depression, Combat Disorders, Stress Disorders, Fatty Acids, Omega-3, Military Personnel, Docosahexaenoic Acids/*therapeutic use, Eicosapentaenoic Acid/*therapeutic use
Brief summary
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.
Interventions
DRUGLovaza, omega-3 fatty acid ethyl ester
Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
DRUGPlacebo, visually identical to Lovaza
Three 1g corn oil capsules/day for three months
Sponsors
GlaxoSmithKline
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary psychometric assessment battery | 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 | 3 months | finger-prick blood spot is collected for determination of fatty acid composition and profile. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| secondary psychometric assessment battery | 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). |
Countries
Iraq
Outcome results
None listed