Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00671099 |
Recruitment Status :
Completed
First Posted : May 5, 2008
Last Update Posted : January 22, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Trauma Posttraumatic Stress Disorder | Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid Dietary Supplement: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
|
Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
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. |
Placebo Comparator: 2
Placebo
|
Dietary Supplement: Placebo
Placebo |
- Total score of Clinician-Administrated PTSD Scale [ Time Frame: Three month ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671099
Japan | |
National Disaster Medical Center | |
Tachikawa, Tokyo, Japan, 1900014 |
Principal Investigator: | Yutaka Matsuoka, M.D.,Ph.D. | National Disaster Medical Center, Tachikawa, Tokyo ,Japan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yutaka Matsuoka, Psychiatrist, Japan Science and Technology Agency |
ClinicalTrials.gov Identifier: | NCT00671099 |
Other Study ID Numbers: |
NDMC-TPOP-02 |
First Posted: | May 5, 2008 Key Record Dates |
Last Update Posted: | January 22, 2014 |
Last Verified: | January 2014 |
Patients with high-energy admitted intensive care unit |
motor vehicle accident falling from height other accident |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |