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Completed

NCT Number: NCT00671489

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Disaster Medical Center, Tachikawa, Tokyo ,Japan

Tachikawa, Tokyo, 190-0014, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 Polyunsaturated Fatty Acid

Dietary 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.

Primary outcomes

  1. Total score of Clinician-Administrated PTSD Scale (CAPS)

    Time frame: Three month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Japan Science and Technology Agency

Other

Collaborators

  • Chiba University
  • University of Toyama

Registry information

Official study title

Phase 2 Study of Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 5, 2008
Registry last updated
Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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