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

NCT01216982 | Unknown Phase 2

• 1 other identifier: M-10023
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• secondary psychometric assessment battery

  3 months

Study Arms (2)

Lovaza, omega-3 fatty acid ethyl ester

ACTIVE COMPARATOR

Drug: Lovaza, omega-3 fatty acid ethyl ester

Placebo

PLACEBO COMPARATOR

one gram corn oil in a soft gelatin capsule

Drug: Placebo, visually identical to Lovaza

Interventions

Lovaza, omega-3 fatty acid ethyl ester DRUG

Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day

Also known as: LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15, Omega-3-Acid Ethyl Esters

Lovaza, omega-3 fatty acid ethyl ester

Placebo, visually identical to Lovaza DRUG

Three 1g corn oil capsules/day for three months

Also known as: Corn oil

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• US Army deployed personnel
• score on a mood questionnaire

You may not qualify if:

• currently consume omega-3 fish oil supplements
• are currently taking antidepressant or other medications for psychiatric purposes
• pregnant
• known fish or shellfish allergy

Sponsors & Collaborators

• United States Department of Defense: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

US Military Base

Camp Taji, 09378, Iraq

Location

MeSH Terms

Conditions

Mood Disorders; Depression; Combat Disorders; Stress Disorders, Traumatic

Interventions

Omacor; Corn Oil

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Daniel T Johnston, MD, MPH

  United States Department of Defense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 9, 2011

Record last verified: 2011-03

Locations

IR (1)