Posttraumatic Stress DisorderNCT00644423
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
A study testing Omega-3 Fatty Acid in people with Posttraumatic Stress Disorder, run by Durham VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Omega-3 Fatty Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2008to 15 Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center
Durham, North Carolina, 27705
About this study
Official title: Omega-3 Fatty Acids and PTSD
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.
Read the detailed description
See brief summary
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Omega-3 Fatty Acid, Placebo
- Keywords
- PTSD, Cognition, Fish Oil, Omega-3 Fatty Acid
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidDrug
Also called Fish Oil
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)
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Omega-3 Fatty Acid Receives: Drug: Omega-3 Fatty Acid |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study start22 Sep 2008
- Primary completion15 Jul 2010
- Study completion15 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Durham VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christine E Marx, MD,MA, Principal investigator, Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644423
- Sponsor's protocol ID
- VA IRB# 01210
- Other IDs
- VA IRB# 01210
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2008
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and PTSD
- ClinicalTrials.gov ID
- NCT00644423
- Acronym / sponsor ID
- VA IRB# 01210
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Cognition, Fish Oil, Omega-3 Fatty Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Durham VA Medical CenterUS federal agency
- Study start
- 22 Sep 2008 (actual)
- Primary completion
- 15 Jul 2010 (actual)
- Study completion
- 15 Jul 2010 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Omega-3 Fatty AcidOmega-3 Fatty Acid |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidAlso: Fish OilOne 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) | Drug | 1 |
| PlaceboMatching Placebo | Drug | 2 |
Primary outcome
Clinician-Administered PTSD Scale (CAPS)
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
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)
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
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).
5 secondary outcomes
Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Connor Davidson Resilience Scale (CD-RISC)
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Continuous Performance Test (CPT)
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Trail Making A
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Trail Making B
Time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine E Marx, MD,MA principal investigator
Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acid in people with Posttraumatic Stress Disorder, run by Durham VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale (CAPS) (time frame: Week 2 (Baseline) and Week 10 (Week 8 Post-Randomization)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.