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

This study has been completed.
Sponsor:
Collaborators:
University of Toyama
Chiba University
Information provided by (Responsible Party):
Yutaka Matsuoka, Japan Science and Technology Agency
ClinicalTrials.gov Identifier:
NCT00671099
First received: May 1, 2008
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Trauma
Posttraumatic Stress Disorder
Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

Resource links provided by NLM:


Further study details as provided by Japan Science and Technology Agency:

Primary Outcome Measures:
  • Total score of Clinician-Administrated PTSD Scale [ Time Frame: Three month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671099

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

Publications:
Responsible Party: Yutaka Matsuoka, Psychiatrist, Japan Science and Technology Agency
ClinicalTrials.gov Identifier: NCT00671099     History of Changes
Other Study ID Numbers: NDMC-TPOP-02
Study First Received: May 1, 2008
Last Updated: January 20, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by 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:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014