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| ID | Type | Description | Link |
|---|---|---|---|
| VA IRB# 01210 |
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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.
See brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Omega-3 Fatty Acid |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acid | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
| 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). | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine E Marx, MD,MA | Durham VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
18 participants enrolled; 11 participants started (randomized at Week 2) after a 2-week placebo lead in
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| ID | Title | Description |
|---|---|---|
| FG000 | Omega-3 Fatty Acid | 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) |
| FG001 | Placebo | Placebo: Matching Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omega-3 Fatty Acid | 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) |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
Adverse Events were collected following the two-week placebo-lead phase and at each subsequent study visit and telephone check-in (every two weeks for 8 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omega-3 Fatty Acid | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sweating | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Marx, MD MA | Durham VA Medical Center | 919-286-0411 | 3626 | marx0001@mc.duke.edu |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
| Placebo | Drug | Matching Placebo |
|
| Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
| 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. | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
| 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. | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
| 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. | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
| 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. | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
Placebo: Matching Placebo |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo: Matching Placebo |
|
|
| Primary | 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). | Posted | Mean | Standard Error | Z-score | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
|
|
| Secondary | 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. | Missing CPT scores from 2 participants in the Omega-3 Fatty Acid arm. | Posted | Mean | Standard Error | Q-score | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | seconds | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | seconds | Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | Placebo | Placebo: Matching Placebo | 0 | 5 | 0 | 5 | 5 | 5 |
| Drowsiness | General disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Excitement/Agitation | General disorders | Systematic Assessment |
|
| Cramps | General disorders | Systematic Assessment |
|
| Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Restlessness | General disorders | Systematic Assessment |
|
| Increased Appetite | General disorders | Systematic Assessment |
|
| Decreased Interest in Sex | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Decreased Appetite | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Disorientation | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Increased Motor Activity | General disorders | Systematic Assessment |
|
| Menstrual Disturbance | Reproductive system and breast disorders | Systematic Assessment |
|
| Muscle Pain/Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Akathisia | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Motor Activity | General disorders | Systematic Assessment |
|
| Hypersomnia | General disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Impaired Sex Performance | General disorders | Systematic Assessment |
|
| Joint Pain/Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasal Congestion | General disorders | Systematic Assessment |
|
| Tremor | General disorders | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |