Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)

Durham VA Medical Center

Status: Completed

Conditions: Posttraumatic Stress Disorder

Treatments: Drug: Placebo; Drug: Omega-3 Fatty Acid

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00644423

VA IRB# 01210

Details and patient eligibility

About

An increasing literature shows that omega-3 fatty acids provide numerous health benefits, including a variety of psychiatric symptoms and disorders including stress, anxiety, cognitive impairment, mood disorders (major depression and bipolar disorder) and schizophrenia. Omega-3 fatty acids may additionally represent a promising treatment strategy in patients with PTSD. Moreover, given its beneficial cardiovascular effects, adjunctive omega-3 fatty acids may also benefit the general health status of these veterans, who frequently present with a variety of comorbid medical disorders.

Full description

See brief summary

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Veterans 18-65 years of age, any ethnic group, either sex.
2. Ability to participate fully in the informed consent process.
3. Current diagnosis of PTSD .
4. No anticipated need to alter medications for the 10-week duration of the study.

Exclusion criteria

1. Serious unstable medical illness, history of traumatic brain injury (TBI) with loss of consciousness greater than 30 minutes, or history of cerebrovascular accident, prostate or breast cancer.
2. Current active suicidal and/or homicidal ideation, intent or plan.
3. Use of aspirin, warfarin or other anticoagulant therapy, as omega-3 fatty acids may increase bleeding time. Other concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
4. Regular use of omega-3 fatty acid supplementation within the last 3 months (cod liver oil, other fish oil, flaxseed).
5. Regular consumption of more than one serving of fatty fish per week.
6. Substance dependence within the last 4 weeks (other than nicotine dependence).
7. Current Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
8. Female patients who are pregnant or breast-feeding.
9. Known allergy to study medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Omega-3 Fatty Acid

Treatment:

Drug: Omega-3 Fatty Acid

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo