Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
July 2, 2012 updated by: Japan Science and Technology Agency
Phase 2 Study of Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
The purpose of this study is to evaluate the efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Tachikawa, Tokyo, Japan, 190-0014
- National Disaster Medical Center, Tachikawa, Tokyo ,Japan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 plus years
- A native Japanese speaking ability
- Possibility 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total score of Clinician-Administrated PTSD Scale (CAPS)
Time Frame: Three month
|
Three month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of diagnosis of PTSD (including partial PTSD)
Time Frame: Three month, one month
|
Three month, one month
|
|
Total score of Montgomery Asberg Depression Rating Scale (MADRAS)
Time Frame: Three month, one month
|
Three month, one month
|
|
Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)
Time Frame: Three month, one month
|
Three month, one month
|
|
Autonomic response measured before, during and after script driven imagery and acoustic stimulation
Time Frame: Three month
|
Three month
|
|
Score of Impact of Event Scale revised (IES-R)
Time Frame: Three month, one month
|
Three month, one month
|
|
Score of Hospital Anxiety and Depression scale (HADS)
Time Frame: Three month, one month
|
Three month, one month
|
|
Score of health related Quality of Life scale, SF-36
Time Frame: Three month, one month
|
Three month, one month
|
|
Score of Conner-Davidson Resilience Scale (CD-RISC)
Time Frame: Three month, one month
|
Three month, one month
|
|
Brain-derived neurotrophic factor (BDNF) in serum
Time Frame: Three month, one month
|
Three month, one month
|
|
Number of days of leave taken from the time of injury
Time Frame: Three month
|
Three month
|
|
Buss-Perry Aggression Questionnaire (BAQ)
Time Frame: Three month, one month, baseline
|
Three month, one month, baseline
|
|
Total score of Clinician-Administrated PTSD Scale (CAPS)
Time Frame: One month
|
One month
|
|
DHEA: dehydroepiandrosterone
Time Frame: Three month, one month
|
Three month, one month
|
|
NPY: neuropeptide Y
Time Frame: Three month, one month
|
Three month, one month
|
|
IL-1 beta: interleukin 1 beta
Time Frame: Three month, one month
|
Three month, one month
|
|
IL-6: interleukin 6
Time Frame: Three month, one month
|
Three month, one month
|
|
TNF alpha: tumor necrosis factor alpha
Time Frame: Three month, one month
|
Three month, one month
|
|
D-serine
Time Frame: Three month, one month
|
Three month, one month
|
|
L-serine
Time Frame: Three month, one month
|
Three month, one month
|
|
DL-serine
Time Frame: Three month, one month
|
Three month, one month
|
|
Activin
Time Frame: Three month, one month
|
Three month, one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yutaka Mastuoka, M.D., Ph.D., National Disaster Medical Center, Tachikawa, Tokyo ,Japan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Hashimoto K, Hamazaki T. Omega-3 fatty acids for secondary prevention of posttraumatic stress disorder after accidental injury: an open-label pilot study. J Clin Psychopharmacol. 2010 Apr;30(2):217-9. doi: 10.1097/JCP.0b013e3181d48830. No abstract available.
- Matsuoka Y. Clearance of fear memory from the hippocampus through neurogenesis by omega-3 fatty acids: a novel preventive strategy for posttraumatic stress disorder? Biopsychosoc Med. 2011 Feb 8;5:3. doi: 10.1186/1751-0759-5-3.
- Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Hamazaki T, Hashimoto K. Potential role of brain-derived neurotrophic factor in omega-3 Fatty Acid supplementation to prevent posttraumatic distress after accidental injury: an open-label pilot study. Psychother Psychosom. 2011;80(5):310-2. doi: 10.1159/000322980. Epub 2011 Jun 30. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
February 1, 2009
Study Completion (ACTUAL)
February 1, 2009
Study Registration Dates
First Submitted
April 23, 2008
First Submitted That Met QC Criteria
May 2, 2008
First Posted (ESTIMATE)
May 5, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 3, 2012
Last Update Submitted That Met QC Criteria
July 2, 2012
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NDMC-TPOP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.