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

Sponsor:	Durham VA Medical Center
Information provided by:	Durham VA Medical Center
ClinicalTrials.gov Identifier:	NCT00644423

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Omega-3 Fatty Acids and PTSD

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Omega-3 Fatty Acid	Drug: Omega-3 Fatty Acid One capsule three times per day x 1 day (325mg EPA/225mg 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)
2: Placebo Comparator 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:

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 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 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.

Contacts and Locations

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

Contacts

Contact: Victoria Payne, MD, MS

(919)286-0411 ext 5566

payne@biac.duke.edu

Locations

United States, North Carolina
Durham VA Medical Center	Recruiting
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 Veterans Affairs Medical Center ( Christine E. Marx, MD )
Study ID Numbers:	VA IRB# 01210, VA IRB# 01210
Study First Received:	March 20, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00644423 History of Changes
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:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on February 08, 2010