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

Sponsor

Japan Science and Technology Agency (Other)

Overall Status

Completed

CT.gov ID

NCT00671489

Collaborator

University of Toyama (Other), Chiba University (Other)

Enrollment

Location

9.1

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma Posttraumatic Stress Disorder	Dietary Supplement: Omega-3 Polyunsaturated Fatty Acid	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Outcome Measures

Primary Outcome Measures

Total score of Clinician-Administrated PTSD Scale (CAPS) [Three month]

Secondary Outcome Measures

Incidence of diagnosis of PTSD (including partial PTSD) [Three month, one month]
Total score of Montgomery Asberg Depression Rating Scale (MADRAS) [Three month, one month]
Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI) [Three month, one month]
Autonomic response measured before, during and after script driven imagery and acoustic stimulation [Three month]
Score of Impact of Event Scale revised (IES-R) [Three month, one month]
Score of Hospital Anxiety and Depression scale (HADS) [Three month, one month]
Score of health related Quality of Life scale, SF-36 [Three month, one month]
Score of Conner-Davidson Resilience Scale (CD-RISC) [Three month, one month]
Brain-derived neurotrophic factor (BDNF) in serum [Three month, one month]
Number of days of leave taken from the time of injury [Three month]
Buss-Perry Aggression Questionnaire (BAQ) [Three month, one month, baseline]
Total score of Clinician-Administrated PTSD Scale (CAPS) [One month]
DHEA: dehydroepiandrosterone [Three month, one month]
NPY: neuropeptide Y [Three month, one month]
IL-1 beta: interleukin 1 beta [Three month, one month]
IL-6: interleukin 6 [Three month, one month]
TNF alpha: tumor necrosis factor alpha [Three month, one month]
D-serine [Three month, one month]
L-serine [Three month, one month]
DL-serine [Three month, one month]
Activin [Three month, one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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