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Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

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ClinicalTrials.gov Identifier: NCT00671099
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : January 22, 2014
Sponsor:
Collaborators:
University of Toyama
Chiba University
Information provided by (Responsible Party):
Yutaka Matsuoka, Japan Science and Technology Agency

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Trauma Posttraumatic Stress Disorder Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid Dietary Supplement: Placebo Phase 3

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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Total score of Clinician-Administrated PTSD Scale [ Time Frame: Three month ]

Secondary Outcome Measures :
  1. Incidence of diagnosis of PTSD (including partial PTSD) [ Time Frame: Three month, one month ]
  2. Total score of Montgomery Asberg Depression Rating Scale (MADRAS) [ Time Frame: Three month, one month ]
  3. Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Three month, one month ]
  4. Autonomic response measured before, during and after script driven imagery and acoustic stimulation [ Time Frame: Three month ]
  5. Score of Impact of Event Scale revised (IES-R) [ Time Frame: Three month, one month ]
  6. Score of Hospital Anxiety and Depression scale (HADS) [ Time Frame: Three month, one month ]
  7. Score of health related Quality of Life scale, SF-36 [ Time Frame: Three month, one month ]
  8. Score of Conner-Davidson Resilience Scale (CD-RISC) [ Time Frame: Three month, one month ]
  9. Brain-derived neurotrophic factor (BDNF) in serum [ Time Frame: Three month, one month ]
  10. Number of days of leave taken from the time of injury [ Time Frame: Three month ]
  11. Buss-Perry Aggression Questionnaire (BAQ) [ Time Frame: Three month, one month, baseline ]
  12. Total score of Clinician-Administrated PTSD Scale (CAPS) [ Time Frame: One month ]
  13. DHEA: dehydroepiandrosterone [ Time Frame: Three month, one month ]
  14. NPY: neuropeptide Y [ Time Frame: Three month, one month ]
  15. IL-1 beta: interleukin 1 beta [ Time Frame: Three month, one month ]
  16. IL-6: interleukin 6 [ Time Frame: Three month, one month ]
  17. TNF alpha: tumor necrosis factor alpha [ Time Frame: Three month, one month ]
  18. D-serine [ Time Frame: Three month, one month ]
  19. L-serine [ Time Frame: Three month, one month ]
  20. DL-serine [ Time Frame: Three month, one month ]
  21. Activin [ Time Frame: Three month, one month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 plus years
  2. A native Japanese speaking ability
  3. Possibility to contact patients with injury in 240 hours, and dosing in oral use
  4. Physical and metal status to possible understands scope and contents in the trial and gets informed consent

Exclusion Criteria:

  1. Clearly irretrievable acute brain parenchyma damage and subdural or subarachnoidal bleeding detected by computed tomography and/or magnetic resonance imaging
  2. Cognitive impairment: Mini Mental State Examination < 24
  3. Heavy drinker or 100IU/L ≦ γGTP in administration
  4. Heavy smoker (over 40 cigarettes per day)
  5. History and current suspicion in diagnosis of psychosis and bipolar I disorder
  6. Suspicion in diagnosis of alcoholic, substance-related disorder and eating disorder
  7. Existence of marked serious symptoms such as suicidal ideation, self-harm behavior, dissociation, status of need rapidly psychiatric treatment
  8. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
  9. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
  10. Habit of eating fish over 4 times per week
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Japan
National Disaster Medical Center
Tachikawa, Tokyo, Japan, 1900014
Sponsors and Collaborators
Japan Science and Technology Agency
University of Toyama
Chiba University
Investigators
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Principal Investigator: Yutaka Matsuoka, M.D.,Ph.D. National Disaster Medical Center, Tachikawa, Tokyo ,Japan
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Yutaka Matsuoka, Japan Science and Technology Agency:
Patients
with high-energy
admitted
intensive care unit
 motor vehicle accident
falling from height
other accident
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders