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

March 8, 2011 updated by: United States Department of Defense

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Camp Taji, Iraq, 09378
        • US Military Base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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:
  • Omega-3-Acid Ethyl Esters
  • LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months
omega-3 fatty acid status
Time Frame: 3 months
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
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Department of Defense

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Daniel T Johnston, MD, MPH, United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Estimate)

March 9, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-10023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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