Mean change scores in posttraumatic stress disorder symptoms (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Group
Value
95% CI
Omega-3 Fatty Acid
-6.50
± 5.124
Placebo
-18.60
± 7.961
Brief Assessment of Cognition in Affective Disorders (BAC-A)Primary· Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores to assess cognitive changes (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The BAC-A includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 10 (Week 2 minus Week 10).
Group
Value
95% CI
Omega-3 Fatty Acid
0.2583
± 0.2078
Placebo
0.2860
± 0.1652
Quick Inventory of Depressive Symptomatology (QIDS)Secondary· Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores in depressive symptomatology (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability, sleep,weight/appetite change, and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity). Higher values reflect more severe symptoms.
Mean change scores in resiliency (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.
Group
Value
95% CI
Omega-3 Fatty Acid
-2.000
± 3.759
Placebo
1.000
± 5.986
Continuous Performance Test (CPT)Secondary· Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores in inpulsivity (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symp
Group
Value
95% CI
Omega-3 Fatty Acid
0.6920
± 0.3369
Placebo
0.6198
± 0.2911
Trail Making ASecondary· Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores in cognition and attention (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a line from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Group
Value
95% CI
Omega-3 Fatty Acid
-3.140
± 2.112
Placebo
-11.14
± 1.570
Trail Making BSecondary· Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Mean change scores in attention and cognition (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part B is a timed test that consists of 25 circles on a piece of paper with both numbers (1 - 13) and letters (A - L); the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The respondent is asked to draw a line from number one, and so on,in correct numerical/alphabetical order, until they
Group
Value
95% CI
Omega-3 Fatty Acid
-20.84
± 11.77
Placebo
-30.65
± 24.17
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks)..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03006016 — Preoperative Omega-3 Polyunsaturated Fatty Acids in Morbidly Obese to Reduce Liver Volume and Steatosis
· NA
· completed
NCT02831582 — Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
· NA
· completed
Other recruiting trials for Posttraumatic Stress Disorder
Currently open trials in the same condition.
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· recruiting
NCT06219408 — CIH Stepped Care for Co-occurring Chronic Pain and PTSD
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· recruiting
NCT07176273 — Adaptive Decision-making And Personalized Treatment for PTSD (ADAPT-PTSD)
· NA
· recruiting
NCT07105345 — Exploring Efficacy of Multi-Mode Cognitive Processing Therapy (CPT) for PTSD
· NA
· recruiting
NCT06608277 — Ketamine, SGB and Combination Treatment for TBI
· Phase 2
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Other Durham VA Medical Center trials
Trials by the same sponsor.
NCT06452446 — Telehealth-based Symptom Management for Veterans Treated With Selinexor
· active not recruiting
NCT06363747 — The Medically Reproducing Bariatric Surgery (MRB) II Study
· Phase 2, PHASE3
· active not recruiting
NCT06142006 — The Diabetes Staging System in Patient Aligned Care Teams
· recruiting
NCT04775589 — Telehealth Stepped Exercise Program for Rural Veterans With Knee Osteoarthritis
· NA
· active not recruiting
NCT01898013 — Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Durham VA Medical Center
Last refreshed: 20 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00644423.