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

Sponsor

United States Department of Defense (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01216982

Collaborator

GlaxoSmithKline (Industry)

256

Enrollment

Location

Arms

Duration (Months)

36.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mood Disorders Depression Combat Disorders Stress Disorders	Drug: Lovaza, omega-3 fatty acid ethyl ester Drug: Placebo, visually identical to Lovaza	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Anticipated Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lovaza, omega-3 fatty acid ethyl ester	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 Other Names: LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15 Omega-3-Acid Ethyl Esters
Placebo Comparator: Placebo one gram corn oil in a soft gelatin capsule	Drug: Placebo, visually identical to Lovaza Three 1g corn oil capsules/day for three months Other Names: Corn oil

Arm

Intervention/Treatment

Active Comparator: Lovaza, omega-3 fatty acid ethyl ester

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

Other Names:

LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15

Omega-3-Acid Ethyl Esters

Placebo Comparator: Placebo

one gram corn oil in a soft gelatin capsule

Drug: Placebo, visually identical to Lovaza

Three 1g corn oil capsules/day for three months

Other Names:

Corn oil

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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