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

Sponsor:	Japan Science and Technology Agency
Collaborators:	University of Toyama Chiba University
Information provided by:	Japan Science and Technology Agency
ClinicalTrials.gov Identifier:	NCT00671099

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets Post-Traumatic Stress Disorder

U.S. FDA Resources

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 ]

Estimated Enrollment:	140
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator 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:

18 plus years
A native Japanese speaking ability
Possibility to 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

Contacts and Locations

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

Contacts

Contact: Yutaka Matsuoka, M.D., Ph.D.	81-42-526-5511 ext 2309	yutaka@ncnp.go.jp
Contact: Daisuke Nishi, M.D.	81-42-526-5511 ext 2309	d-nishi@tdmc.hosp.go.jp

Locations

Japan, Tokyo
National Disaster Medical Center	Recruiting
Tachikawa, Tokyo, Japan, 1900014
Contact: Yutaka Matsuoka, M.D., Ph.D. 81-42-526-5511 ext 2309 yutaka@ncnp.go.jp
Contact: Daisuke Nishi, M.D. 81-42-526-5511 ext 2309 d-nishi@tdmc.hosp.go.jp
Principal Investigator: Matsuoka Yutaka, M.D., Ph.D.

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

No publications provided

Responsible Party:	National Disaster Medical Center and National Center of Neurology and Psychiatry ( Matsuoka Yutaka )
Study ID Numbers:	NDMC-TPOP-02
Study First Received:	May 1, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00671099 History of Changes
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:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on November 25, 2009