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

NCT00644423 | Completed Results

• 1 other identifier: VA IRB# 01210
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; Cognition; Fish Oil; Omega-3 Fatty Acid

Outcome Measures

Primary Outcomes (2)

• Clinician-Administered PTSD Scale (CAPS)

  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.

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

• Brief Assessment of Cognition in Affective Disorders (BAC-A)

  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).

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

Secondary Outcomes (5)

• Quick Inventory of Depressive Symptomatology (QIDS)

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

• Connor Davidson Resilience Scale (CD-RISC)

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

• Continuous Performance Test (CPT)

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

• Trail Making A

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

• Trail Making B

  Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)

Study Arms (2)

1

ACTIVE COMPARATOR

Omega-3 Fatty Acid

Drug: Omega-3 Fatty Acid

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Omega-3 Fatty Acid DRUG

One capsule three times per day x 1 day (325mg EPA/225mg docosahexaenoic acid (DHA) tid) Two capsules three times per day x 1 day (650mg EPA/450mg DHA tid) Three capsules three times per day thereafter (975mg EPA/675mg DHA tid)

Also known as: Fish Oil

1

Placebo DRUG

Matching Placebo

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Fatty Acids, Omega-3; Fish Oils

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Christine Marx, MD MA
• Organization: Durham VA Medical Center

marx0001@mc.duke.edu

919-286-0411

Study Officials

• Christine E Marx, MD,MA

  Durham VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2008
• First Posted: March 26, 2008
• Study Start: September 22, 2008
• Primary Completion: July 15, 2010
• Study Completion: July 15, 2010
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Locations

US (1)