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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644423
Recruitment Status : Active, not recruiting
First Posted : March 26, 2008
Last Update Posted : July 28, 2017
Information provided by (Responsible Party):
Durham VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: Omega-3 Fatty Acid Drug: Placebo Not Applicable

Detailed Description:
See brief summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids and PTSD
Study Start Date : September 2008
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Omega-3 Fatty Acid
Drug: Omega-3 Fatty Acid
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)
Other Name: Fish Oil
Placebo Comparator: 2
Drug: Placebo
Matching Placebo

Primary Outcome Measures :
  1. Our primary outcome measures will be the Clinician-Administered PTSD Scale (CAPS) and the Brief Assessment of Cognition in Affective Disorders (BAC-A) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Secondary outcome measures include the Quick Inventory of Depressive Symptomatology (QIDS) , the Connor Davidson Resilience Scale, the Continuous Performance Test (CPT), and Trail Making A+B [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00644423

United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Principal Investigator: Christine E Marx, MD,MA Durham VA Medical Center

Responsible Party: Durham VA Medical Center Identifier: NCT00644423     History of Changes
Other Study ID Numbers: VA IRB# 01210
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Keywords provided by Durham VA Medical Center:
Fish Oil
Omega-3 Fatty Acid

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders