Clinical trial NCT00644423: Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
Official title: Omega-3 Fatty Acids and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Cognition
Fish Oil
Omega-3 Fatty Acid
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2008-03-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: See brief summary

Eligibility 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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
measure: Brief Assessment of Cognition in Affective Disorders (BAC-A)
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Secondary outcomes:
measure: Quick Inventory of Depressive Symptomatology (QIDS)
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
measure: Connor Davidson Resilience Scale (CD-RISC)
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
measure: Continuous Performance Test (CPT)
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
measure: Trail Making A
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
measure: Trail Making B
timeFrame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center
name: Christine E Marx, MD,MA
role: PRINCIPAL_INVESTIGATOR
References: