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

Phase 2

• Conditions: Mood Disorders; Depression; Combat Disorders; Stress Disorders
• Interventions: Drug: Lovaza, omega-3 fatty acid ethyl ester; Drug: Placebo, visually identical to Lovaza

• Registration Number: NCT01216982
• Lead Sponsor: United States Department of Defense

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Study Start: 2010-11
• Primary Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-08
• Last Update Posted: 2011-03-09
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lovaza, omega-3 fatty acid ethyl ester	Lovaza, omega-3 fatty acid ethyl ester	-
Placebo	Placebo, visually identical to Lovaza	one gram corn oil in a soft gelatin capsule

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

US Military Base; 🇮🇶 Camp Taji, Iraq