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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

Tracking Information
First Submitted Date  ICMJE May 1, 2008
First Posted Date  ICMJE May 5, 2008
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE December 2008
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
Total score of Clinician-Administrated PTSD Scale [ Time Frame: Three month ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
Total score of Clinical-Administrated PTSD Scale [ Time Frame: Three month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2008)
  • Incidence of diagnosis of PTSD (including partial PTSD) [ Time Frame: Three month ]
  • Total score of Montgomery Asberg Depression Rating Scale (MADRAS) [ Time Frame: Three month ]
  • Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: Three 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Official Title  ICMJE Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Trauma
  • Posttraumatic Stress Disorder
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
    Intervention: Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
  • Placebo Comparator: 2
    Placebo
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2014)
110
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2008)
140
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00671099
Other Study ID Numbers  ICMJE NDMC-TPOP-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yutaka Matsuoka, Japan Science and Technology Agency
Study Sponsor  ICMJE Japan Science and Technology Agency
Collaborators  ICMJE
  • University of Toyama
  • Chiba University
Investigators  ICMJE
Principal Investigator: Yutaka Matsuoka, M.D.,Ph.D. National Disaster Medical Center, Tachikawa, Tokyo ,Japan
PRS Account Japan Science and Technology Agency
Verification Date January 2014

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