Mood DisordersPhase 2NCT01216982
Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders
A Phase 2 study testing Lovaza, omega-3 fatty acid ethyl ester in people with Mood Disorders and Depression, run by United States Department of Defense at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorders, Depression, Combat Disorders
- What is being tested?
- Lovaza, omega-3 fatty acid ethyl ester
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteIraq
- Study dates
- Nov 2010to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- US Army deployed personnel
- score on a mood questionnaire
Who cannot join
- currently consume omega-3 fish oil supplements
- are currently taking antidepressant or other medications for psychiatric purposes
- pregnant
- known fish or shellfish allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mood Disorders, Depression, Combat Disorders, Stress Disorders
- Being tested
- Lovaza, omega-3 fatty acid ethyl ester, Placebo, visually identical to Lovaza
- Keywords
- Mood Disorders, Depression, Combat Disorders, Stress Disorders, Fatty Acids, Omega-3, Military Personnel, Docosahexaenoic Acids/*therapeutic use, Eicosapentaenoic Acid/*therapeutic use
- Medical subject headings
- Mood Disorders, Depression, Combat Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovaza, omega-3 fatty acid ethyl esterDrug
Also called LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15, Omega-3-Acid Ethyl Esters
Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
Placebo, visually identical to LovazaDrug
Also called Corn oil
Three 1g corn oil capsules/day for three months
| Study group | Role | What they receive |
|---|---|---|
| Lovaza, omega-3 fatty acid ethyl ester | Active comparator | Not described Receives: Drug: Lovaza, omega-3 fatty acid ethyl ester |
| Placebo | Placebo comparator | one gram corn oil in a soft gelatin capsule Receives: Drug: Placebo, visually identical to Lovaza |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary psychometric assessment battery
Specific components include:
Zung Depression Scale (ZDS) Zung Anxiety Scale (ZAS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)
Measured: 3 months
omega-3 fatty acid status
finger-prick blood spot is collected for determination of fatty acid composition and profile.
Measured: 3 months
Secondary outcomes (1)
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Collaborators
- GlaxoSmithKline
- Investigators
- Daniel T Johnston, MD, MPH, Principal investigator, United States Department of Defense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216982
- Sponsor's protocol ID
- M-10023
- Status last verified
- Mar 2011
- First submitted
- 6 Oct 2010
- Last updated
- 9 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial
- ClinicalTrials.gov ID
- NCT01216982
- Acronym / sponsor ID
- M-10023
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovaza, omega-3 fatty acid ethyl ester | Active comparator | Drug: Lovaza, omega-3 fatty acid ethyl ester |
| Placebo | Placebo comparator | Drug: Placebo, visually identical to Lovazaone gram corn oil in a soft gelatin capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- US Army deployed personnel
- score on a mood questionnaire
Key exclusion criteria (4 listed)
- currently consume omega-3 fish oil supplements
- are currently taking antidepressant or other medications for psychiatric purposes
- pregnant
- known fish or shellfish allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovaza, omega-3 fatty acid ethyl esterAlso: LOVAZA 1g Soft Gelatin Capsules NDC NO. 65726-425-15, Omega-3-Acid Ethyl EstersThree 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day | Drug | Lovaza, omega-3 fatty acid ethyl ester |
| Placebo, visually identical to LovazaAlso: Corn oilThree 1g corn oil capsules/day for three months | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
secondary psychometric assessment battery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel T Johnston, MD, MPH principal investigator
United States Department of Defense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lovaza, omega-3 fatty acid ethyl ester in people with Mood Disorders and Depression, run by United States Department of Defense at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary psychometric assessment battery (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2011.