N/A
N=11
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00644423 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Clinician-Administered PTSD Scale (CAPS) — -6.50; -18.60 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Omega-3 Fatty Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Durham VA Medical Center
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
-6.50; -18.60 | — |
| PRIMARY Brief Assessment of Cognition in Affective Disorders (BAC-A) |
0.2583; 0.2860 | — |
| SECONDARY Quick Inventory of Depressive Symptomatology (QIDS) |
1.167; -1.000 | — |
| SECONDARY Connor Davidson Resilience Scale (CD-RISC) |
-2.000; 1.000 | — |
| SECONDARY Continuous Performance Test (CPT) |
0.6920; 0.6198 | — |
| SECONDARY Trail Making A |
-3.140; -11.14 | — |
| SECONDARY Trail Making B |
-20.84; -30.65 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Veterans 18-65 years of age, any ethnic group, either sex.
- Ability to participate fully in the informed consent process.
- Current diagnosis of PTSD .
- No anticipated need to alter medications for the 10-week duration of the study.
Exclusion Criteria
- 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.
- Current active suicidal and/or homicidal ideation, intent or plan.
- 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.
- Regular use of omega-3 fatty acid supplementation within the last 3 months (cod liver oil, other fish oil, flaxseed).
- Regular consumption of more than one serving of fatty fish per week.
- Substance dependence within the last 4 weeks (other than nicotine dependence).
- 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.
- Female patients who are pregnant or breast-feeding.
- Known allergy to study medication.
Data sourced from ClinicalTrials.gov (NCT00644423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.