Clinical trial NCT00671099: Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Official title: Tachikawa Project for Prevention of Posttraumatic Stress Disorder With Polyunsaturated Fatty Acid (TPOP): TPOP-02 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Trauma
Posttraumatic Stress Disorder
Keywords: Patients
with high-energy
admitted
intensive care unit
motor vehicle accident
falling from height
other accident
Lead sponsor: Japan Science and Technology Agency
Sponsor class: OTHER
Collaborators: name: University of Toyama
name: Chiba University
First posted: 2008-05-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility 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

Primary outcomes:
measure: Total score of Clinician-Administrated PTSD Scale
timeFrame: Three month
Secondary outcomes:
measure: Incidence of diagnosis of PTSD (including partial PTSD)
timeFrame: Three month, one month
measure: Total score of Montgomery Asberg Depression Rating Scale (MADRAS)
timeFrame: Three month, one month
measure: Incidence of depression evaluated by Mini-International Neuropsychiatric Interview (MINI)
timeFrame: Three month, one month
measure: Autonomic response measured before, during and after script driven imagery and acoustic stimulation
timeFrame: Three month
measure: Score of Impact of Event Scale revised (IES-R)
timeFrame: Three month, one month
measure: Score of Hospital Anxiety and Depression scale (HADS)
timeFrame: Three month, one month
measure: Score of health related Quality of Life scale, SF-36
timeFrame: Three month, one month
measure: Score of Conner-Davidson Resilience Scale (CD-RISC)
timeFrame: Three month, one month
measure: Brain-derived neurotrophic factor (BDNF) in serum
timeFrame: Three month, one month
measure: Number of days of leave taken from the time of injury
timeFrame: Three month
measure: Buss-Perry Aggression Questionnaire (BAQ)
timeFrame: Three month, one month, baseline
measure: Total score of Clinician-Administrated PTSD Scale (CAPS)
timeFrame: One month
measure: DHEA: dehydroepiandrosterone
timeFrame: Three month, one month
measure: NPY: neuropeptide Y
timeFrame: Three month, one month
measure: IL-1 beta: interleukin 1 beta
timeFrame: Three month, one month
measure: IL-6: interleukin 6
timeFrame: Three month, one month
measure: TNF alpha: tumor necrosis factor alpha
timeFrame: Three month, one month
measure: D-serine
timeFrame: Three month, one month
measure: L-serine
timeFrame: Three month, one month
measure: DL-serine
timeFrame: Three month, one month
measure: Activin
timeFrame: Three month, one month
Other outcomes:
Locations:
city: Tachikawa
country: Japan
facility: National Disaster Medical Center
state: Tokyo
Study officials:
affiliation: National Disaster Medical Center, Tachikawa, Tokyo ,Japan
name: Yutaka Matsuoka, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matsuoka Y, Nishi D, Yonemoto N, Hamazaki K, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Tachikawa project for prevention of posttraumatic stress disorder with polyunsaturated fatty acid (TPOP): study protocol for a randomized controlled trial. BMC Psychiatry. 2013 Jan 5;13:8. doi: 10.1186/1471-244X-13-8.
citation: Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
citation: Matsuoka Y, Nishi D, Hamazaki K, Yonemoto N, Matsumura K, Noguchi H, Hashimoto K, Hamazaki T. Docosahexaenoic acid for selective prevention of posttraumatic stress disorder among severely injured patients: a randomized, placebo-controlled trial. J Clin Psychiatry. 2015 Aug;76(8):e1015-22. doi: 10.4088/JCP.14m09260.
citation: Matsuoka Y, Nishi D, Tanima Y, Itakura M, Kojima M, Hamazaki K, Noguchi H, Hamazaki T. Serum pro-BDNF/BDNF as a treatment biomarker for response to docosahexaenoic acid in traumatized people vulnerable to developing psychological distress: a randomized controlled trial. Transl Psychiatry. 2015 Jul 7;5(7):e596. doi: 10.1038/tp.2015.89.