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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT00644423
First received: March 20, 2008
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Drug: Omega-3 Fatty Acid
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids and PTSD

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Placebo Comparator: 2
Placebo
Drug: Placebo
Matching Placebo

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644423

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

No publications provided

Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT00644423     History of Changes
Other Study ID Numbers: VA IRB# 01210, VA IRB# 01210
Study First Received: March 20, 2008
Last Updated: September 24, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014