---
title: Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders
nct_id: NCT01216982
overall_status: UNKNOWN
phase: PHASE2
sponsor: United States Department of Defense
study_type: INTERVENTIONAL
primary_condition: Mood Disorders
countries: Iraq
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01216982.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01216982"
ct_last_update_post_date: 2011-03-09
last_seen_at: "2026-05-12T06:10:38.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01216982](https://clinicaltrials.gov/study/NCT01216982)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 256
- **Lead Sponsor:** United States Department of Defense
- **Collaborators:** GlaxoSmithKline
- **Conditions:** Mood Disorders, Depression, Combat Disorders, Stress Disorders
- **Start Date:** 2010-11
- **Completion Date:** 2011-06
- **CT.gov Last Update:** 2011-03-09

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **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
```

## Arms

- **Lovaza, omega-3 fatty acid ethyl ester** (ACTIVE_COMPARATOR)
- **Placebo** (PLACEBO_COMPARATOR) — one gram corn oil in a soft gelatin capsule

## 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
- **Placebo, visually identical to Lovaza** (DRUG) — Three 1g corn oil capsules/day for three months

## Primary Outcomes

- **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)
- **omega-3 fatty acid status** _(time frame: 3 months)_ — finger-prick blood spot is collected for determination of fatty acid composition and profile.

## Secondary Outcomes

- **secondary psychometric assessment battery** _(time frame: 3 months)_

## Locations (1)

- US Military Base, Camp Taji, Iraq

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.us military base|camp taji||iraq` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01216982.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01216982*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*
