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

Primary Purpose

Mood Disorders, Depression, Combat Disorders

Status
Unknown status
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Lovaza, omega-3 fatty acid ethyl ester
Placebo, visually identical to Lovaza
Sponsored by
United States Department of Defense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mood Disorders focused on measuring Mood Disorders, Depression, Combat Disorders, Stress Disorders, Fatty Acids, Omega-3, Military Personnel, Docosahexaenoic Acids/*therapeutic use, Eicosapentaenoic Acid/*therapeutic use

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • US Military Base

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lovaza, omega-3 fatty acid ethyl ester

Placebo

Arm Description

one gram corn oil in a soft gelatin capsule

Outcomes

Primary Outcome Measures

primary psychometric assessment battery
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
finger-prick blood spot is collected for determination of fatty acid composition and profile.

Secondary Outcome Measures

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).

Full Information

First Posted
October 6, 2010
Last Updated
March 8, 2011
Sponsor
United States Department of Defense
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01216982
Brief Title
Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders
Official Title
Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
United States Department of Defense
Collaborators
GlaxoSmithKline

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Depression, Combat Disorders, Stress Disorders
Keywords
Mood Disorders, Depression, Combat Disorders, Stress Disorders, Fatty Acids, Omega-3, Military Personnel, Docosahexaenoic Acids/*therapeutic use, Eicosapentaenoic Acid/*therapeutic use

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lovaza, omega-3 fatty acid ethyl ester
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one gram corn oil in a soft gelatin capsule
Intervention Type
Drug
Intervention Name(s)
Lovaza, omega-3 fatty acid ethyl ester
Other Intervention Name(s)
LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15, Omega-3-Acid Ethyl Esters
Intervention Description
Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
Intervention Type
Drug
Intervention Name(s)
Placebo, visually identical to Lovaza
Other Intervention Name(s)
Corn oil
Intervention Description
Three 1g corn oil capsules/day for three months
Primary Outcome Measure Information:
Title
primary psychometric assessment battery
Description
Specific components include: Zung Depression Scale (ZDS) Zung Anxiety Scale (ZAS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)
Time Frame
3 months
Title
omega-3 fatty acid status
Description
finger-prick blood spot is collected for determination of fatty acid composition and profile.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
secondary psychometric assessment battery
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel T Johnston, MD, MPH
Organizational Affiliation
United States Department of Defense
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Military Base
City
Camp Taji
ZIP/Postal Code
09378
Country
Iraq

12. IPD Sharing Statement

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

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