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

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.

Study Overview

• Status: Completed
• Conditions: Trauma; Posttraumatic Stress Disorder
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Omega-3 Polyunsaturated Fatty Acid

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: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Tachikawa, Tokyo, Japan, 1900014
      • National Disaster Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2; Placebo	Dietary supplement: Placebo; Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total score of Clinician-Administrated PTSD Scale	Three month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Japan Science and Technology Agency
• Collaborators: University of Toyama; Chiba University
• Investigators: Principal Investigator: Yutaka Matsuoka, M.D.,Ph.D., National Disaster Medical Center, Tachikawa, Tokyo ,Japan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (ESTIMATE): May 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: intensive care unit; Patients; motor vehicle accident; with high-energy; admitted; falling from height; other accident
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NDMC-TPOP-02