Back to resultsOmega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Cognition, Fish Oil, Omega-3 Fatty Acid
Eligibility 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 (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.
- 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 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.
Sites / Locations
- Durham VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Omega-3 Fatty Acid
Placebo
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Quick Inventory of Depressive Symptomatology (QIDS)
Mean change scores in depressive symptomatology (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability, sleep,weight/appetite change, and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity). Higher values reflect more severe symptoms.
Connor Davidson Resilience Scale (CD-RISC)
Mean change scores in resiliency (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.
Continuous Performance Test (CPT)
Mean change scores in inpulsivity (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Trail Making A
Mean change scores in cognition and attention (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a line from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Trail Making B
Mean change scores in attention and cognition (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part B is a timed test that consists of 25 circles on a piece of paper with both numbers (1 - 13) and letters (A - L); the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The respondent is asked to draw a line from number one, and so on,in correct numerical/alphabetical order, until they reach number 13. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00644423
Brief Title
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
Official Title
Omega-3 Fatty Acids and PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 22, 2008 (Actual)
Primary Completion Date
July 15, 2010 (Actual)
Study Completion Date
July 15, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durham VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Cognition, Fish Oil, Omega-3 Fatty Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Omega-3 Fatty Acid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Omega-3 Fatty Acid
Other Intervention Name(s)
Fish Oil
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS)
Description
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.
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Title
Brief Assessment of Cognition in Affective Disorders (BAC-A)
Description
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).
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology (QIDS)
Description
Mean change scores in depressive symptomatology (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The QIDS total scores range from 0 to 27. Total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV Major Depressive Disorder (MDD) criteria: depressed mood,loss of interest or pleasure,concentration/decision making,self-outlook,suicidal ideation, energy/fatigability, sleep,weight/appetite change, and psychomotor changes. Each item is rated 0-3 (0=least or no severity, 3=greatest severity). Higher values reflect more severe symptoms.
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Title
Connor Davidson Resilience Scale (CD-RISC)
Description
Mean change scores in resiliency (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Title
Continuous Performance Test (CPT)
Description
Mean change scores in inpulsivity (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Title
Trail Making A
Description
Mean change scores in cognition and attention (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a line from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Title
Trail Making B
Description
Mean change scores in attention and cognition (Week 10 (Week 8 Post-Randomization) minus Week 2 (Baseline)). Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part B is a timed test that consists of 25 circles on a piece of paper with both numbers (1 - 13) and letters (A - L); the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The respondent is asked to draw a line from number one, and so on,in correct numerical/alphabetical order, until they reach number 13. Results are reported as the number of seconds required to complete the task. Higher scores indicate greater impairment.
Time Frame
Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 (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.
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Marx, MD,MA
Organizational Affiliation
Durham VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
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