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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial

Conditions
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Mood Disorders, Depression, Combat Disorders, Stress Disorders

Intervention / Treatment
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* Drug: Lovaza, omega-3 fatty acid ethyl ester
* Drug: Placebo, visually identical to Lovaza


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lovaza, omega-3 fatty acid ethyl ester<br> | Drug: Lovaza, omega-3 fatty acid ethyl ester<br>* Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day<br>* Other names: Omega-3-Acid Ethyl Esters;|
| Placebo Comparator: Placebo<br>one gram corn oil in a soft gelatin capsule | Drug: Placebo, visually identical to Lovaza<br>* Three 1g corn oil capsules/day for three months<br>* Other names: Corn oil;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary psychometric assessment battery | 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). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mood Disorders, Depression, Combat Disorders, Stress Disorders, Fatty Acids, Omega-3, Military Personnel, Docosahexaenoic Acids/*therapeutic use, Eicosapentaenoic Acid/*therapeutic use