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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01216982
• Other study ID #: M-10023
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 6, 2010
• Last updated: March 8, 2011
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2011
• Source: United States Department of Defense
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Combat Disorders
• Depression
• Disease
• Mood Disorders
• Stress Disorders
• Stress Disorders, Traumatic

Intervention

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
• Placebo, visually identical to Lovaza
Three 1g corn oil capsules/day for three months

Locations

Country	Name	City	State
Iraq	US Military Base	Camp Taji

Sponsors (2)

Lead Sponsor	Collaborator
United States Department of Defense	GlaxoSmithKline

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	omega-3 fatty acid status	finger-prick blood spot is collected for determination of fatty acid composition and profile.	3 months	No
Secondary	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).	3 months	No