TraumaPhase 3NCT00671099
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
A Phase 3 study testing Omega-3 Polyunsaturated Fatty Acid in people with Trauma and Posttraumatic Stress Disorder, run by Japan Science and Technology Agency at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Posttraumatic Stress Disorder
- What is being tested?
- Omega-3 Polyunsaturated Fatty Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2008to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 plus years
- A native Japanese speaking ability
- Possibility to contact patients with injury in 240 hours, and dosing in oral use
- Physical and metal status to possible understands scope and contents in the trial and gets informed consent
Who cannot join
- Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
- Cognitive impairment: Mini Mental State Examination < 24
- Heavy drinker or 100IU/L ≦ γGTP in administration
- Heavy smoker (over 40 cigarettes per day)
- History and current suspicion in diagnosis of psychosis and bipolar I disorder
- Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
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- Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
- Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
- Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
- Habit of eating fish over 4 times per week
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.
Read the detailed description
Accidental injuries, mostly motor vehicle accident, in civilian population are frequent events.For instance, nearly one-third of injured patients appear to develop trauma-related psychiatric illness and the major diagnoses are post-traumatic stress disorder (PTSD) and depressive disorder.Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA) has some evidence of efficacy of treatment in patients with anxiety and mood disorders, but no evidence of preventing anxiety and mood disorders that occur subsequent to accidental injuries.We evaluate efficacy and safety of Omega-3 PUFA for the secondary prevention of Posttraumatic Stress Disorder (PTSD) and related psychiatric illness in patients with accidental injury
- Conditions
- Trauma, Posttraumatic Stress Disorder
- Being tested
- Omega-3 Polyunsaturated Fatty Acid, Placebo
- Keywords
- Patients, with high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident
- Medical subject headings
- Wounds and Injuries, 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 Polyunsaturated Fatty AcidDietary supplement
A capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 70% docosahexaenoic acid, 7% eicosapentaenoic acid and other), 7 capsules per day in 12 week.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid Receives: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid |
| 2 | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of Clinician-Administrated PTSD Scale
Measured: Three month
Secondary outcomes (21)
Incidence of diagnosis of PTSD (including partial PTSD)
Measured: Three month, one month
Total score of Montgomery Asberg Depression Rating Scale (MADRAS)
Measured: Three month, one month
Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)
Measured: Three month, one month
Autonomic response measured before, during and after script driven imagery and acoustic stimulation
Measured: Three month
Score of Impact of Event Scale revised (IES-R)
Measured: Three month, one month
Score of Hospital Anxiety and Depression scale (HADS)
Measured: Three month, one month
Score of health related Quality of Life scale, SF-36
Measured: Three month, one month
Score of Conner-Davidson Resilience Scale (CD-RISC)
Measured: Three month, one month
Brain-derived neurotrophic factor (BDNF) in serum
Measured: Three month, one month
Number of days of leave taken from the time of injury
Measured: Three month
Buss-Perry Aggression Questionnaire (BAQ)
Measured: Three month, one month, baseline
Total score of Clinician-Administrated PTSD Scale (CAPS)
Measured: One month
DHEA: dehydroepiandrosterone
Measured: Three month, one month
NPY: neuropeptide Y
Measured: Three month, one month
IL-1 beta: interleukin 1 beta
Measured: Three month, one month
IL-6: interleukin 6
Measured: Three month, one month
TNF alpha: tumor necrosis factor alpha
Measured: Three month, one month
D-serine
Measured: Three month, one month
L-serine
Measured: Three month, one month
DL-serine
Measured: Three month, one month
Activin
Measured: Three month, one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startDec 2008
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Science and Technology Agency
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toyama, Chiba University
- Responsible party
- Principal investigator, Yutaka Matsuoka, Japan Science and Technology Agency
- Investigators
- Yutaka Matsuoka, M.D.,Ph.D., Principal investigator, National Disaster Medical Center, Tachikawa, Tokyo ,Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671099
- Sponsor's protocol ID
- NDMC-TPOP-02
- Status last verified
- Jan 2014
- First submitted
- 1 May 2008
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial. BMC Psychiatry. 2013 Jan 5;13:8. doi: 10.1186/1471-244X-13-8.
PubMed 23289548Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
PubMed 35141873Matsuoka Y, Nishi D, Hamazaki K, Yonemoto N, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Docosahexaenoic acid for selective prevention of posttraumatic stress disorder among severely injured patients: a randomized, placebo-controlled trial. J Clin Psychiatry. 2015 Aug;76(8):e1015-22. doi: 10.4088/JCP.14m09260.
PubMed 26335087Matsuoka Y, Nishi D, Tanima Y, Itakura M, Kojima M, Hamazaki K, Noguchi H, Hamazaki T. Serum pro-BDNF/BDNF as a treatment biomarker for response to docosahexaenoic acid in traumatized people vulnerable to developing psychological distress: a randomized controlled trial. Transl Psychiatry. 2015 Jul 7;5(7):e596. doi: 10.1038/tp.2015.89.
PubMed 26151924
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
- ClinicalTrials.gov ID
- NCT00671099
- Acronym / sponsor ID
- NDMC-TPOP-02
- Conditions
- Trauma, Posttraumatic Stress Disorder
- Keywords
- Patients, with high-energy, admitted, intensive care unit, motor vehicle accident, falling from height, other accident
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Japan Science and Technology AgencyUniversity, hospital or other
- Collaborators
- University of Toyama, Chiba University
- Study start
- Dec 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.
Detailed description
Accidental injuries, mostly motor vehicle accident, in civilian population are frequent events.For instance, nearly one-third of injured patients appear to develop trauma-related psychiatric illness and the major diagnoses are post-traumatic stress disorder (PTSD) and depressive disorder.Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA) has some evidence of efficacy of treatment in patients with anxiety and mood disorders, but no evidence of preventing anxiety and mood disorders that occur subsequent to accidental injuries.We evaluate efficacy and safety of Omega-3 PUFA for the secondary prevention of Posttraumatic Stress Disorder (PTSD) and related psychiatric illness in patients with accidental injury
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Omega-3 Polyunsaturated Fatty AcidDietary Supplement: Omega-3 Polyunsaturated Fatty Acid |
| 2 | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 plus years
- A native Japanese speaking ability
- Possibility to contact patients with injury in 240 hours, and dosing in oral use
- Physical and metal status to possible understands scope and contents in the trial and gets informed consent
Key exclusion criteria (10 listed)
- Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
- Cognitive impairment: Mini Mental State Examination < 24
- Heavy drinker or 100IU/L ≦ γGTP in administration
- Heavy smoker (over 40 cigarettes per day)
- History and current suspicion in diagnosis of psychosis and bipolar I disorder
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 Polyunsaturated Fatty AcidA capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 70% docosahexaenoic acid, 7% eicosapentaenoic acid and other), 7 capsules per day in 12 week. | Dietary supplement | 1 |
| PlaceboPlacebo | Dietary supplement | 2 |
Primary outcome
Total score of Clinician-Administrated PTSD Scale
Time frame: Three month
21 secondary outcomes
Incidence of diagnosis of PTSD (including partial PTSD)
Time frame: Three month, one month
Total score of Montgomery Asberg Depression Rating Scale (MADRAS)
Time frame: Three month, one month
Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)
Time frame: Three month, one month
Autonomic response measured before, during and after script driven imagery and acoustic stimulation
Time frame: Three month
Score of Impact of Event Scale revised (IES-R)
Time frame: Three month, one month
Score of Hospital Anxiety and Depression scale (HADS)
Time frame: Three month, one month
Score of health related Quality of Life scale, SF-36
Time frame: Three month, one month
Score of Conner-Davidson Resilience Scale (CD-RISC)
Time frame: Three month, one month
Brain-derived neurotrophic factor (BDNF) in serum
Time frame: Three month, one month
Number of days of leave taken from the time of injury
Time frame: Three month
Buss-Perry Aggression Questionnaire (BAQ)
Time frame: Three month, one month, baseline
Total score of Clinician-Administrated PTSD Scale (CAPS)
Time frame: One month
DHEA: dehydroepiandrosterone
Time frame: Three month, one month
NPY: neuropeptide Y
Time frame: Three month, one month
IL-1 beta: interleukin 1 beta
Time frame: Three month, one month
IL-6: interleukin 6
Time frame: Three month, one month
TNF alpha: tumor necrosis factor alpha
Time frame: Three month, one month
D-serine
Time frame: Three month, one month
L-serine
Time frame: Three month, one month
DL-serine
Time frame: Three month, one month
Activin
Time frame: Three month, one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Background: PubMed 23289548Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial. BMC Psychiatry. 2013 Jan 5;13:8. doi: 10.1186/1471-244X-13-8.
- Derived from this study: PubMed 38767196Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.
- Derived from this study: PubMed 35141873Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
- Derived from this study: PubMed 26335087Matsuoka Y, Nishi D, Hamazaki K, Yonemoto N, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Docosahexaenoic acid for selective prevention of posttraumatic stress disorder among severely injured patients: a randomized, placebo-controlled trial. J Clin Psychiatry. 2015 Aug;76(8):e1015-22. doi: 10.4088/JCP.14m09260.
- Derived from this study: PubMed 26151924Matsuoka Y, Nishi D, Tanima Y, Itakura M, Kojima M, Hamazaki K, Noguchi H, Hamazaki T. Serum pro-BDNF/BDNF as a treatment biomarker for response to docosahexaenoic acid in traumatized people vulnerable to developing psychological distress: a randomized controlled trial. Transl Psychiatry. 2015 Jul 7;5(7):e596. doi: 10.1038/tp.2015.89.
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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.
Yutaka Matsuoka, M.D.,Ph.D. principal investigator
National Disaster Medical Center, Tachikawa, Tokyo ,Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 Polyunsaturated Fatty Acid in people with Trauma and Posttraumatic Stress Disorder, run by Japan Science and Technology Agency at 1 site in Japan.
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 10 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 22 Jan 2014. 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 Japan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total score of Clinician-Administrated PTSD Scale (time frame: Three month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671099, which also lists 5 linked publications.
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 22 Jan 2014.