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Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
This study has been completed.
Study NCT00671489   Information provided by Japan Science and Technology Agency
First Received: April 23, 2008   Last Updated: May 4, 2009   History of Changes

April 23, 2008
May 4, 2009
May 2008
February 2009   (final data collection date for primary outcome measure)
Total score of Clinician-Administrated PTSD Scale (CAPS) [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
Total score of Clinical-Administrated PTSD Scale (CAPS) [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00671489 on ClinicalTrials.gov Archive Site
  • Incidence of diagnosis of PTSD (including partial PTSD) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Total score of Montgomery Asberg Depression Rating Scale (MADRAS) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Autonomic response measured before, during and after script driven imagery and acoustic stimulation [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
  • Score of Impact of Event Scale revised (IES-R) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Score of Hospital Anxiety and Depression scale (HADS) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Score of health related Quality of Life scale, SF-36 [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • Score of Conner-Davidson Resilience Scale (CD-RISC) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Brain-derived neurotrophic factor (BDNF) in serum [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Number of days of leave taken from the time of injury [ Time Frame: Three month ] [ Designated as safety issue: No ]
  • Buss-Perry Aggression Questionnaire (BAQ) [ Time Frame: Three month, one month, baseline ] [ Designated as safety issue: No ]
  • Total score of Clinician-Administrated PTSD Scale (CAPS) [ Time Frame: One month ] [ Designated as safety issue: Yes ]
  • DHEA: dehydroepiandrosterone [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • NPY: neuropeptide Y [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • IL-1 beta: interleukin 1 beta [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • IL-6: interleukin 6 [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • TNF alpha: tumor necrosis factor alpha [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • D-serine [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • L-serine [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • DL-serine [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • Activin [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • Incidence of diagnosis of PTSD (including partial PTSD) [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
  • Total score of Montgomery Asberg Depression Rating Scale (MADRAS) [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
  • Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
  • Autonomic response measured before, during and after script driven imagery and acoustic stimulation [ Time Frame: Three month ] [ Designated as safety issue: Yes ]
  • Score of Impact of Event Scale revised (IES-R) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Score of Hospital Anxiety and Depression scale (HADS) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Score of health related Quality of Life scale, SF-36 [ Time Frame: Three month, one month ] [ Designated as safety issue: No ]
  • Score of Conner-Davidson Resilience Scale (CD-RISC) [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Brain-derived neurotrophic factor (BDNF) in serum [ Time Frame: Three month, one month ] [ Designated as safety issue: Yes ]
  • Number of days of leave taken from the time of injury [ Time Frame: Three month ] [ Designated as safety issue: No ]
 
Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-01 Study
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.

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.

Phase I, Phase II
Interventional
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Prevention
  • Trauma
  • Posttraumatic Stress Disorder
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.
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
15
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 plus years
  2. A native Japanese speaking ability
  3. Possibility 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00671489
Matsuoka Yutaka, National Disaster Medical Center and National Center of Neurology and Psychiatry
NDMC-TPOP-01
Japan Science and Technology Agency
  • University of Toyama
  • Chiba University
Principal Investigator: Yutaka Mastuoka, M.D., Ph.D. National Disaster Medical Center, Tachikawa, Tokyo ,Japan
Japan Science and Technology Agency
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP